Pfizer, BioNTech reach 40-million dose agreement with COVAX

Pfizer and BioNTech SE announced an advance purchase agreement with COVAX for up to 40 million doses of their Covid-19 vaccine. Financial terms of the agreement were not disclosed, but the doses are expected to delivered throughout 2021, beginning in Q1.

COVAX is a global initiative coordinated by the Global Alliance for Vaccines and Immunization (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), intended to provide fair access to Covid-19 vaccines for all countries, regardless of income levels. COVAX includes an Advanced Market Commitment (AMC) financial mechanism that aims to ensure that 92 low- and lower-middle-income countries will be able to secure access to Covid-19 vaccines at the same time as higher-income countries, so that they can distribute them accordingly.

Regarding the COVAX Advanced Market Commitment, 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price.

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SkyCell and Korean Air form transportation partnership

SkyCell, a manufacturer of data-driven temperature-controlled containers for the pharma industry, has partnered with Korean Air Cargo as it focuses on business development in Korea.

The partnership comes at a time when there is an increase in demand for Covid-19 vaccines and treatments this year. Cold-chain maintenance for vaccine transportation is one of several challenges faced by the global logistics industry—SkyCell and Korean Air are working to help these medicines reach patients in a timely manner.

SkyCell’s hybrid containers allow pharma companies to optimize supply chains using data to predict and control risk. Using over three-quarters of a billion datapoints on factors like temperature, location and time, the company makes note of audited failure rates of less than 0.1%, while reducing carbon dioxide emissions by almost half.

In 2019, Korean Air was awarded the International Air Transport Association (IATA)’s Centre of Excellence for Independent Validators (CEIV) Pharma certification. CEIV Pharma is an international standard that indicates an airline’s ability to manage pharmaceuticals, including the handling procedure, equipment and facilities. More than 280 checklists are evaluated by validators to authorize the certification.

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Vault introduces Covid-19 vaccination platform

As the coronavirus pandemic continues, Vault Health, a healthcare company that offers a supervised at-home and on-site saliva Covid-19 testing platform, has released an on-demand, turnkey vaccination administration tool. Vault works with state and local governments to build mass vaccination sites to provide immunizations to thousands of residents every day.

The business created a tech platform that provides analytics and patient engagement, generating a reporting process that the company says can be implemented with government health systems, and scaled a network of 3,000+ healthcare professionals available through video supervision or in-person to make Covid-19 testing widely accessible. Vault partnered with local and state governments across the US on full-service polymerase chain reaction (PCR) and antigen testing programs, including with Minnesota featuring at-home, on-site and pop-up testing events.

Vault is looking to replicate the logistics of on-site Covid testing sites to create micro-to-mega vaccination sites that can help in administering the Covid-19 vaccine across the country. A statewide push could reach 30,000+ patients daily, depending on allocation. Vault is currently working with state partners to develop vaccination programs.

Jason Feldman, the company’s founder and CEO, notes that Vault has created a database of partners, ranging from the public sector to pharma. He believes that the platform has the strong potential to expand across the US.

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BioNTech raises vaccine distribution goal to 2 billion doses

BioNTech SE, Pfizer’s vaccine development partner, has boosted the 2021 delivery target for its Covid-19 vaccine to 2 billion doses, an increase from its previous projection of 1.3 billion, due to the addition of new production lines and as more doses can be extracted per vial, according to a Reuters report.

The company mentioned yesterday—in a presentation for the virtual JP Morgan healthcare conference—that a new manufacturing site in Marburg, Germany, acquired from Novartis in September, could help increase annual capacity by up to 750 million doses when it becomes operational by the end of February. Special syringes known as low dead space syringes allow for extraction of six vaccine doses from a standard vial, instead of the usual five, which can avoid wasting unused liquid left in a syringe, Reuters notes.

BioNTech mentioned that this would result in 1 billion people getting the designated two-dose regimen, the report says.

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Kuehne+Nagel will distribute Moderna’s vaccine

Moderna and Kuehne+Nagel have reached an international supply chain arrangement to provide distribution and storage of Moderna’s Covid-19 mRNA vaccine. The news comes after the vaccine was granted conditional market authorization (CMA) by the European Commission last week.

The arrangement includes distribution and warehousing of the vaccine from Kuehne+Nagel’s Europe-based pharma hub. The logistics company will use its network of more than 230 operations worldwide to distribute the vaccine via road and air. In Europe, the company operates its own fleet of over 200 dedicated pharma transport vehicles—besides this region, distribution will also be to Asia, the Middle East and parts of the Americas. At all stages of transport and storage, product temperature will remain at the required -20°C (-4°F).

Kuehne+Nagel has also signed partnerships with officials in various countries for local storage and last-mile distribution, including in Germany’s most populous state, North Rhine-Westphalia.

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Bayer and CureVac team up on potential vaccine

Bayer has signed an agreement with CureVac N.V., a biopharma company that manufactures medication based on messenger ribonucleic acid (mRNA). Per the deal, Bayer will help with development, supply and territory operations of CureVac’s Covid-19 vaccine candidate, CVnCoV.

As of Dec. 14, the vaccine has been in Phase IIb/III.

Bayer will offer its perspective in areas including clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance.

CureVac will be the marketing authorization (MA) holder for the product, while Bayer will support CureVac with country operations in the EU and other markets. Bayer also holds options to become MA holder in markets outside of Europe. The companies plan to work together on enabling CureVac to supply hundreds of millions of CVnCoV doses internationally, if approvals are granted.

In November 2020, CureVac announced that it would expand up its European manufacturing network, working with Wacker and Fareva, among others.

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New IATA air freight data released

November data for global air freight markets showed that freight volumes improved over October, but remain low when compared to 2019, according to the latest numbers from the International Air Transport Association (IATA). Capacity remains limited, due to the loss of available belly cargo space, as passenger aircrafts are at a standstill.

Global demand, measured in cargo tonne-kilometers (CTKs), was down 6.6% from last year’s November numbers (-7.7% for international operations). This was consistent with the 6.2% year-on-year drop in October. However, the year-on-year decline is skewed, as November 2019 saw an increase in demand from the US-China trade war.

Global capacity, which is measured in available cargo tonne-kilometers (ACTKs), shrank by 20% in November (‑21.3% for international operations) compared to 2019, making it almost three times larger than the contraction in demand. The capacity issues can be attributed to a 53% decrease in belly capacity. This has been partially offset by a 20% boost in freighter capacity.

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European Commission approves Moderna vaccine

After Moderna recently said it would increase its global supply of its Covid-19 vaccine, today, the EU’s executive commission—formally known as the European Commission—has officially granted conditional market authorization (CMA) for the vaccine. The news comes after the European Medicines Agency (EMA) recommended its authorization earlier in the day.

From a distribution standpoint, this greenlights the move of 160 million doses that are expected to be delivered to the EU between Q1 and Q3.

Pfizer and BioNTech SE, whose vaccine had previously been granted CMA in December, reached a deal to supply the EU with an additional 100 million doses this year, bringing the total to 300 million. And yesterday, Bloomberg reported that there are now talks to acquire up to 300 million additional doses, though nothing has been finalized yet.

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Moderna raises vaccine supply estimate

Moderna said it will increase supply of its Covid-19 vaccine, from its original base-case global production estimate of 500 million to at least 600 million doses for 2021. The company stated that it is continuing to invest and hire staff to build up to potentially 1 billion doses for the year.

Domestically, Moderna said it expects about 100 million doses to be available in the US by the end of Q1, with 200 million available by the end of Q2. The biotech reported that approximately 18 million doses have been supplied to the US government to date. Its vaccine received emergency use authorization from the FDA on Dec. 18 for individuals 18 years or age and older.

The news comes after Pfizer and BioNTech SE announced a second agreement before the holidays with the US government to supply an additional 100 million doses of their vaccine from production facilities in North America, bringing the total number of expected delivered doses to 200 million.

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Pfizer to supply US with 100 million more doses of vaccine

Pfizer and development partner BioNTech SE announced a second agreement with the US government to supply an additional 100 million doses of the companies’ Covid-19 vaccine from production facilities in North America. This agreement brings the total number of doses to be delivered to the US to 200 million. The companies expect to deliver the full 200 million doses to Operation Warp Speed (OWS) by July 31, 2021. Consistent with the original agreement announced in July, the US government will pay $1.95 billion for the additional 100 million doses.

Under the terms of the second agreement, Pfizer and Germany-based BioNTech will deliver at least 70 million of the additional doses by June 30, 2021, with the remaining 30 million doses to be delivered no later than July 31. The US also has the option to acquire up to an additional 400 million doses. 

According to the companies’ joint release, eligible US residents will continue to receive the vaccine for free, consistent with the government’s commitment to providing free access for Covid vaccines and according to CDC Advisory Committee on Immunization Practices (ACIP) recommendations for the vaccine’s phased rollout.  

The Pfizer-BioNTech vaccine has not been approved or licensed by the FDA, but has been authorized for emergency use by the agency for individuals 16 years of age and older.

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IATA makes case that aviation employees be deemed essential for vaccination

The International Air Transport Association (IATA) asked governments to acknowledge that employees in the aviation sector be considered essential workers during the Covid-19 vaccine campaign, once healthcare workers and vulnerable groups have been protected.

Alexandre de Juniac, IATA’s director general and CEO, is not calling for governments to change priorities, but rather to consider the role that those in the aviation industry play in the global supply chain.

“We are not asking for aviation workers to be on top of the list, but we need governments to ensure that transportation workers are considered as essential when vaccine roll-out plans are developed,” he said. “The transportation of the Covid-19 vaccines has already begun, and as calculations show, it will require the equivalent of 8,000 Boeing 747 freighter aircraft for global distribution. It is therefore essential that we have the qualified workforce in place to ensure a functioning logistics chain.”

IATA’s 76th Annual General Meeting (AGM) recently adopted a resolution speaking to this effect.

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Pelican BioThermal unveils ‘School of Cool’

Pelican BioThermal introduced School of Cool, an online learning platform that’s goal is to help customers and distributors build proficiency in temperature-controlled packaging technology. The new training program provides on-demand, self-service training at a time when instruction has taken a virtual shift, while demand for these types of packaging options continues to increase.

School of Cool is used to develop and provide content for various industries, such as pharma, healthcare, biotech and general business. The first four training modules the company offers include:

  • What is Temperature Controlled Packaging? – Introduces new and potential customers to the temperature-controlled packaging industry and the mechanical properties of insulation.
  • Types of Temperature Controlled Packaging – Explains the types of temperature-controlled packaging and optimal use case for each, including payload capacities and temperature ranges.
  • Phase Change Material – Brings attention to the types of phase change materials and how they maintain designated temperature ranges throughout the entire product transport.
  • Phase Change Material Conditioning – Covers how to prepare temperature-controlled packaging coolants for use before pack out.

Plans to add more lessons are in the works, including those that address product temperature ranges, parcels versus pallets, dry ice shippers and Pelican BioThermal’s new NanoCool push-button cooling technology, which was part of an acquisition the company made early this year.

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CCT involved in OWS’s vaccine distribution efforts

Cold Chain Technologies (CCT) was a supplier of specialty thermal packaging for the storage and transfer of Covid-19 vaccines in support of the US government’s Operation Warp Speed (OWS) distribution plan.

Although no two scenarios are alike, Ranjeet Banerjee, the company’s CEO, notes that CCT’s experience in similar situations, such as H1N1, have helped from a logistical standpoint.

“Our company is prepared, ready and able to leverage both our deep experience of delivering for past pandemics and the expanded capacity we have been building since the COVID-19 pandemic began to meet the temperature-sensitive requirements of the vaccine—with the industry’s broadest portfolio of single-use and reusable systems for parcel and pallet shipments,” he said.

CCT opened a new 255,000 sq.-ft. cold-chain facility in Lebanon, TN, last month.

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Covid-19 vaccine is here, but supplies will be tight

The Pfizer-BioNTech vaccine is here, approved by FDA under an emergency use authorization (EUA) on Dec. 11. The Moderna version (also based on mRNA technology, and from a company that has never had a commercially approved product) is expected to have an FDA public hearing on Dec. 17; if the Pfizer-BioNTech pattern holds, that product could be approved the next day.

Extraordinary excitement—and no little anxiety—has built up over how the vaccine will be delivered to the US population quickly. But the realities, at this point, appear to be that a) distribution providers—wholesalers and third-party logistics providers like UPS and FedEx—are well-adapted to delivering the temperature-controlled products; b) there won’t be much flowing through the system initially.

According to press reports and FDA statements, only 2.9 million doses of the Pfizer product will be on hand for administration, starting Dec. 14. And while it’s possible, at least in the near term, to administer all of those to patients immediately, the health officials will administer only half, pending later deliveries, to ensure that patients get the second dose three weeks later. (Moderna’s vaccine calls for a second dose after four weeks.) By comparison, there are 21 million healthcare workers, and three million long-term care patients—the two groups tagged as first in line for vaccination—nationally.

President Trump issued another executive order on Dec. 8 claiming priority for supplying vaccines to Americans first, but given that the Pfizer vaccine is already being supplied to the UK, Canada and Bahrain, and Moderna has commercial agreements with the EU, Canada, Japan and other countries, Trump’s action is more symbolic than substantive. Together, Pfizer and Moderna hope to deliver 25 million doses in the US by the end of the year.

On Dec. 8, the White House’s Operation Warp Speed program held a Vaccine Summit (the relevant comments begin around 1:18 into the video) at which representatives of McKesson, UPS and FedEx presented. McKesson is responsible for delivering vaccines other than Pfizer’s (although there is coordination going on with the company) as well as the kits containing supplies for vaccine administration. UPS is handling, mostly, the US east of the Mississippi, and FedEx the western portion. UPS Healthcare’s president, Wes Wheeler, demo’d the materials the company will use: insulated boxes from Softbox and Cold Chain Technologies, an end-to-end tracking device (for location and environmental conditions) from Controlant, and its own RFID tag, and Sentry GPS system, that is read at UPS way stations. FedEx is using its own SenseAware device for location and environmental monitoring, and FedEx Surround, a predictive analytics monitoring system. UPS is also preparing to send supplemental dry ice, alone, through its network, from dry ice production capacity it has installed.

There have been numerous statements to the effect that the vaccine-distribution process is a monumental undertaking (The New York Times called it “a challenge of staggering proportions”), but the delivery companies pooh-poohed these concerns. UPS’ Wheeler noted that while hundreds or thousands of vaccine parcels might be in transit soon, the company handled 34 million packages through its network on Dec. 7 (the day before the Summit). FedEx’s Richard Smith, regional president, allayed concerns that there are enough cargo aircraft available; his own company could, in theory, manage delivery to the entire world itself in a short period of time (of course, many other carriers are and will be involved). Deliveries on this scale “is what we do every day,” he said.

State-level efforts

Operation Warp Speed and the CDC are deciding how to allocate vaccine shipments among 50 states and territories, but after that, most of the decisions will be made at the state and local level, including what priority is given to which citizens. Fifty states have 50 plans (Kaiser Health News consolidated all these plans, as of mid-October, here).

At least one state—Louisiana—is relying on an in-state wholesaler for local distribution for certain categories of dispensing locations. Paul Dickson, president of Morris & Dickson, says the company is handling delivery to 200 medical facilities that are not major hospital locations. It has installed sufficient ultra-cold storage for 750,000 doses of the Pfizer vaccine, and contracted with a local dry ice supplier to provide up to 4,000 lb of dry ice weekly. It will be able to receive vaccine from Pfizer and deliver to facilities the same or next day. (Morris & Dickson operates in 18 states across the Southeast and Midwest, but so far, no other state has asked it to step in.)

Like the UPS and FedEx representatives, Dickson is bullish that vaccine distribution will proceed smoothly. “In our everyday business, we’re tracking 30,000 products being delivered daily across a wide region,” he says. “We have our part to do, and we plan to do it well.”

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HDA foundation captures specialty Rx distributor trends

New data released by the Healthcare Distribution Alliance (HDA) Research Foundation points to the supply chain efficiencies generated by HDA-member specialty drug distributors. According to the latest edition of Specialty Pharmaceutical Distribution: Facts, Figures and Trends, specialty distributors serve as an important link between 176 manufacturers and more than 49,000 provider ship-to points for administration or dispensing to patients. In citing data from IQVIA, HDA noted that the specialty pharma market reached $426 billion in 2019.

Independent physician-owned and -operated clinics make up the biggest customer segment (about 18,000), followed by hospitals, retail pharmacies and specialty pharmacies. As in years past, oncology products accounted for the highest shipping volume, at 52% of specialty distributors’ weighted average sales, followed by products in the inflammatory/autoimmune, supportive care, ophthalmology and hemophilia/bleeding disorder groups.

The primary data are gathered through a survey of HDA specialty distributors who have recorded yearly sales greater than $1 billion for the 2019 fiscal year; they also have combined average gross specialty sales of $23 billion. The Covid-19 response is not reflected in this particular publication.

Among the 2019 highlights:

  • On average, specialty distributors received more than 4,500 orders daily. Each distribution center typically picked nearly 7,300 lines daily, with an average of 2.8 lines per order.
  • Distributors achieved a 98.8% order fill rate on average and delivered 1.4 days after receiving an order. The typical turnaround time from courier pickup to delivery to the dispenser was 18.3 hours.
  • A majority of distributors (75%) reported using temperature-monitoring devices to track shipments of specialty pharmaceuticals at various points in the supply chain. The same amount believe that overall cold-chain compliance and temperature monitoring are becoming increasingly important.

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Schreiner MediPharm joins tracking standardization consortium

Schreiner MediPharm, a German specialty label developer, has joined DoseID, the US-based industry association launched in August that works to standardize the use of RFID tags in healthcare. The company is focused closely on this technology—in fact, it augmented its Cap-Lock tamper-evident specialty label with an RFID inlay in October.

DoseID’s goal is to monitor the performance of RFID-tagged drug products as they move through the pharma supply chain. The products are tracked across all hardware and software systems—from the manufacturer, through the distributor, to the hospital and ultimately, the patient.

Pharmaceuticals can be tracked by serializing medications, containers and devices, but the RFID tags need perform well in hospital and healthcare IT systems—otherwise, the products won’t be able to be tracked from start to finish.

The unit level serialization supported by DoseID exceeds the requirements set forth by the Drug Supply Chain Security Act (DSCSA). To ensure adherence to the standards established by the consortium and conformity with the requirements of pharmaceutical manufacturers, compounding pharmacies, pharmacy automation services providers and manufacturers of RFID inlays and tags, a special RFID tag certification also is awarded after third-party testing.

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Carrier Pods to help tackle Covid-19 vaccine storage demands

SeaCube Containers LLC acquired 200 Carrier Pods monitored by Sensitech to help combat the projected need for refrigerated storage capacity and cargo visibility in support of Covid-19 vaccine distribution.

Carrier Pods temporary storage unit. Credit: Carrier Transicold

As previously reported by Pharmaceutical Commerce, the systems offer deep-frozen container refrigeration with telematics, data analytics and most recently, remote cargo monitoring capabilities. Both Carrier and Sensitech are part of Carrier Global Corp., which offers building and cold chain solutions.

With Carrier Pods monitored by Sensitech, container refrigeration units deliver temperature control within +/- 0.25 ºC (32.45 ºF, 31.55 ºF) and temperatures down to -40 ºC (-40 ºF), while their monitoring devices are able to track readings down to dry ice conditions of -95 ºC (-139 ºF). Sensitech noted the devices’ simple mobility, which allows them to easily relocate, whether it be to meet changing capacity demands or go to temporary vaccine administration locations.

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Latest IATA numbers suggest a mixed bag for air cargo

October data for global air freight markets showed that air cargo demand is improving, but at a slower speed than September, according to the International Air Transport Association (IATA)’s latest data. It also remains below previous year levels.

Global demand, measured in cargo tonne-kilometers (CTKs), was 6.2% below previous-year levels in October (-7.5% for international operations). That is an improvement from the 7.8% year-on-year drop recorded in September. However, the pace of recovery in October was slower than in September, with month-on-month demand growing 4.1% (1.1% for international).

Similar to September, global capacity—measured in available cargo tonne-kilometers (ACTKs)—was also a concern this time around, shrinking by 22.6% in October (‑24.8% for international operations) compared to the year before. That is almost four times larger than the contraction in demand, illustrating the continuing and severe capacity issue.

North American and African carriers reported year-on-year gains in demand (+6.2% and +2.2% respectively), while all other regions remained in the negative, versus October 2019.

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Tjoapack invests $12M in Netherlands facility

Tjoapack, a contract packaging organization (CPO) for the pharma industry, has invested $12.1 million into its packaging and supply chain facility in Etten-Leur, Netherlands over the next two years.

The location will expand from approximately 90,417 sq. ft. to about 123,785 sq. ft. in size, adding eight new production lines to double capacity for primary packaging for oral solids to over four billion tablets per year. Further, the company’s team is expected to double with the hiring of 100 employees.

Other than the growth in production capacity, Tjoapack said it will be “investing heavily” in both its warehousing and cold chain capabilities to meet the increased customer demand for the company’s logistics services.

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Vaccine storage & packaging market to balloon to $43.8B

The global vaccine storage and packaging market is projected to jump to $43.8 billion by 2027, according to a new study published by Polaris Market Research.

The market is also expecting a compound annual growth rate (CAGR) of 10.4% from 2020 to 2027. Technological advancements in the storage and packaging of medicines, a climb in the number of pharma retailers and an increase in the prevalence of infectious diseases are projected to drive demand for the worldwide market.

The Covid-19 pandemic has caused a rise in research studies for the development of a vaccine to prevent and cure the disease, as well as demand for reliable storage and packaging solutions to store these vaccines—doses such as Pfizer’s that use synthetic mRNA to activate the immune system against the virus have to be stored at -70 ºC (-94 ºF).

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DoKaSch and Air Europa expand pharma product capabilities

DoKaSch Temperature Solutions and Air Europa have signed a master rental agreement for the use of DoKaScho’s temperature-controlled Opticooler packaging solution. The partnership opens up new direct routes between Europe and Latin America, giving forwarders and pharma producers additional transport options.

DoKaSch’s Opticooler RAP container. Credit: DoKaSch Temperature Solutions

DoKaSch’s airfreight container comes in two sizes: there is the RKN version that holds 1.5 Euro pallets (one CP1 pallet), while the RAP version—which United Cargo utilized last April—offers space for up to five Euro pallets (four CP1 pallets). The Opticooler is capable of keeping the desired temperature level between 2 and 8 ºC (35.6 and 46.4 ºF) at all times, regardless of the surrounding climate. It is equipped with batteries and only requires a power socket for charging.

Air Europa, an airline based in Spain’s capital city of Madrid, offers flights within Europe, to Africa and the Americas. At the moment, it is providing direct flights with wide-body aircrafts from Madrid to 21 destinations in Latin America.

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Latest HDA Factbook outlines supply chain trends

Data published yesterday by the Healthcare Distribution Alliance (HDA) Research Foundation revealed that in 2019, approximately 93% of all US pharma sales were completed through HDA-member traditional pharmaceutical distributors. As reported in the 91st Edition HDA Factbook, total distributor sales were $519 billion.

The Factbook is based on surveys collected at the corporate level of HDA traditional distributor member companies with yearly sales greater than $1 billion, along with secondary data included from healthcare and governmental organizations. The data reflect distribution industry performance metrics and overall supply chain management trends for the 2019 operating year; it should be noted that this edition does not reflect the effects of Covid-19 on supply chain operations.

Prescription drugs accounted for about $420 billion of distributors’ overall pharmaceutical sales, representing a nearly 6% growth over 2018—distributors worked with more than 1,400 manufacturer suppliers.

Among the other findings:

  • On a typical business day, each traditional distribution center picked more than 105,000 SKUs and processed about 4,000 orders.
  • The average total amount of SKUs that distributors held in inventory was 45,645; prescription medicines represented 76% of total lines picked, with non-prescription drugs (health and personal care products, general merchandise and durable medical equipment and home healthcare) making up the remaining 24%.
  • Forty percent of distributors are currently using EPCIS 1.2—a GS1 standard that allows partners to gather content about supply chain events—for serialized data exchange (a requirement for 2023 Drug Supply Chain Security Act interoperability), with 60% reporting they plan to do so in the next 12 months.

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World Courier opens new sites in Asia, Africa

World Courier’s new Kenya office. Credit: World Courier

World Courier, a specialty logistics company, opened a new clinical and commercial storage depot in Istanbul, Turkey, along with a new office in Nairobi, Kenya.

Given the city’s large population and location in the Eastern-Europe-Middle East-North African triangle, the company’s Turkey depot will serve as a clinical and commercial storage facility. It offers the advantage of allowing sponsors to utilize in-country depot storage, as opposed to direct-to-site shipments, which the company says can help mitigate any temperature deviation issues.

The opening of the new Kenya office comes at a time when governments across the globe are planning for the rollout of Covid-19 vaccines and formulating distribution plans in regions, such as Sub-Saharan Africa that may have limited logistics infrastructure (internet, cargo facilities, roads)—high temperatures and lack of rainfall are also concerns. World Courier notes that the GxP (good practice)-compliant location is conveniently near the Nairobi airport—with enough fridge and freezer capacity for packaging—and should help strengthen local supply chains.

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CSafe Global unveils an innovative look into shipment GPS

CSafe Global, a provider of powered, temperature-controlled air-freight containers for pharmaceuticals has officially launched the company’s real-time shipment visibility platform and technology, which was built by Cloudleaf, Inc. in collaboration with CSafe operations.

CSafe customer shipment visibility dashboard. Credit: CSafe Global

The company began adding new location and condition-tracking sensors to its active RKN and RAP containers, which, according to Tom Weir, CSafe’s COO, have received FAA approval for tracking device integration.

The program provides alerts and notifications directly to customers via email, text or in the platform itself regarding the following information:

  • Cargo temperature outside set parameters
  • Door open events
  • Ambient temperature change outside set parameters
  • Shock event
  • Tilt event
  • Ambient pressure changes outside set parameters
  • Ambient humidity changes outside set parameters
  • Route deviations or delays

CSafe customers who use this new program will also receive other standard benefits, such as the ability to request and manage leases, monitor shipments in real-time and access historical shipments.

Earlier this year, CSafe nearly tripled the size of its San Juan, PR container station.

 

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Targeting Middle East logistics, companies demonstrate vaccine proactivity

As part of the “1 million kilos” charitable initiative, Kuehne+Nagel and Qatar Airways Cargo have donated air freight services to UNICEF to help combat Covid-19.

Members of the Hope Consortium. Credit: the Hope Consortium

The “1 million kilos” initiative is part of the larger sustainability “We Qare” project of Qatar Airways Cargo, in which the airline is donating one million kilos (2.2 million pounds) of freight for humanitarian aid including medical supplies, such as protective equipment, until the end of 2020. The one million kilos are allocated to freight forwarders to give to charities of their choice.

In other parts of the Middle East, the city of Abu Dhabi (United Arab Emirates) is also facilitating coronavirus vaccine distribution efforts by launching the Hope Consortium, whose mission is to tackle all supply chain-related concerns related to coronavirus vaccines: transport, demand planning, sourcing, training, digital technology infrastructure and assisting with availability. The group is expected to be able to handle over six billion vaccine doses (single or multi doses) in cold and ultra-cold conditions in 2021, which will increase to over three times more doses by the end of next year.

Distribution of the treatments, which will be stored in Abu Dhabi Ports Company warehouses, will be carried out by Etihad Cargo, the first Middle Eastern carrier to gain IATA’s Center of Excellence for Independent Validators (CEIV) certification for pharmaceutical logistics; the company provides end-to-end thermal shipping, and on behalf of Abu Dhabi’s Department of Health, transported five million vaccines this past month.

Other consortium members consist of the aforementioned Abu Dhabi Ports Group, Rafed, the healthcare purchasing piece of Abu Dhabi-based ADQ, and SkyCell, which creates temperature-controlled containers for the pharma industry, including hybrid ones. The technology is constantly tracking conditions to make sure that inoculations are protected. With insulation and cooling technology, the containers are able to maintain a steady climate for an average of 202 hours (8.4 days) and self-recharge automatically in a cooling chamber or reefer truck. The Switzerland-based manufacturer will have a regional service and manufacturing location in Abu Dhabi.

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Logistics providers gear up for Covid-19 distribution

In a few weeks, if all goes well with FDA reviews and approvals, Pfizer’s Covid-19 vaccine will begin to be administered to healthcare workers in the US, followed by Moderna’s. We will immediately begin hearing about, on the one hand, well-connected people of any background getting the vaccine, and on the other hand, people saying there’s no way they’ll allow a rapidly developed vaccine approved by a suspect process of the current administration to enter their veins. Fast forward a year or so, and a variety of vaccines will be available at multiple outlets (hospitals, pharmacies, doctors’ offices), and the campaigns to encourage more vaccinations will begin to get boring.

Between now and then, vaccine makers, governments and contract logistics providers will be making multiple choices over how to move the vaccines from their manufacturing sites to the point of dispensing, across the US and around the world. Already, some outlines of this process are beginning to emerge, based on various press sources.

On Nov. 27, the Wall Street Journal reported that United Air Cargo is beginning to ship Pfizer’s vaccine from sites in Kalamazoo, MI, and Puurs, Belgium. Pfizer has opted to perform its own distribution, sidestepping both the US military’s management of distribution (under Operation Warp Speed) as well as the contract let to McKesson Corporation, the US’ leading wholesaler-distributor, by the Centers for Disease Control and Prevention (CDC). Pfizer, according to multiple press reports, is also avoiding the use of active (powered) air freight containers that can ship pallets worth of drugs under temperature control. Rather, it has opted for case-level passive packaging, loaded with dry ice—perhaps to take advantage of the simplified next step in distribution, to move these cases from, say, an airport warehouse to multiple dispensing points. (Delivery of a pallet would necessitate breaking down the pallet to individual cases, along with potentially requiring repackaging.)

Pfizer’s vaccine requires storage at -70 °C (-94 °F); Moderna’s at -20°C (-4 °F); both are well below the conventional 2-8 °C (35.6-46.4 °F) setpoint for refrigerated pharmaceuticals.

United Air Cargo, according to the WSJ, has requested an exemption from an FAA requirement to limit the amount of dry ice on an aircraft; this limit exists because the carbon dioxide gas emitted from warming dry ice is a hazard to breathing. Wide-body aircrafts have a limit of 1,088 kg (2,399 lb) of dry ice typically, according to a DHL analysis, “Delivering Pandemic Resilience”; FAA will allow United to carry 6,804 kg (15,000 lb).

More to come

Depending on who’s counting, and the global location, there are well over 100 Covid-19 vaccines in development; and about a half-dozen in clinical trials expected to be reviewed by FDA for the US market. These include others based on mRNA; viral-vector vaccines; protein fragments (of the coronavirus); and deactivated coronavirus itself. Leading candidates include a viral vector type from AstraZeneca and Oxford University, and a similar one from Johnson & Johnson.

J&J received a $1 billion-contract from the US government for its 100 million doses of its vaccine, now in a Phase III trial. There are two potential advantages to the J&J route: a single dose (rather than the two required by Pfizer and Moderna); and 2-8 °C (35.6-46.4 °F) storage and shipping.

Luis Roman, global VP of delivery at J&J’s Janssen subsidiary, says the company is already well along in establishing manufacturing locations, warehousing and shipping for its vaccine. The vaccine is fill-finished at a Catalent facility in Wiley, IN, and Leiden, Netherlands; other “nodes,” as he puts it, are in the works. “We are leveraging the clinical capabilities of our logistics partners as we prepare for the commercial distribution,” he noted. The company has committed to 600 million dosages by the end of next year, with half of that committed to the US market. The current Phase III trial has 60,000 participants.

The 2-8 °C (35.6-46.4 °F) temperature requirement of the vaccine will allow the company to utilize standard containers and storage measures for refrigerated pharmaceuticals. In addition, the company is planning to track distribution with “real time location tags” on final packages (this implies use of RFID technology, although Roman would not confirm that).

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Supply chain management giant doubles down on Covid fight

In response to the challenge associated with the storage and transportation of cold chain products, including frozen vaccines for Covid-19, UPS Healthcare, which continued major expansion this summer, can now create up to 1,200 pounds of dry ice per hour in its US facilities. That output is in line with manufacturer storage requirements. UPS will also make dry ice accessible for US and Canadian hospitals, clinics and other points of care that need dry ice to store vaccines locally on premises.

Stirling ULT25 NEU. Credit: UPS

Together with Stirling Ultracold, UPS is also unveiling portable ultra-low temperature (ULT) freezers—including the Stirling ULT25 and the more compact SU105—which can store vaccines at temperatures from -20°C to -80°C (-4 °F to -112 °F). Both will be dispensed in smaller locations that will be using freezer storage for extended periods.

Dusty Tenney, Stirling’s CEO, who has been outspoken about the effort required to distribute ULT-mandated vaccines for Covid-19, commented: This program will help ensure vaccines remain effective next year, and for years to come, as future vaccines and biologics are developed to keep the world healthy and safe.”

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Partnership links immunotherapy and AI

Building on a business relationship that was established in 2019, BioNTech SE and InstaDeep Ltd have struck a multi-year partnership that, companies say, will employ the most up-to-date developments in artificial intelligence (AI) and machine learning (ML) technology to develop novel immunotherapies, including vaccines, for cancers and infectious diseases, such as Covid-19.

As part of the collaboration, the companies will form a joint AI Innovation Lab in both London and Mainz, Germany, to advance various plans surrounding drug discovery and design, protein engineering, manufacturing and supply chain optimization. The lab will combine InstaDeep’s expertise in AI, ML and digitalization alongside BioNTech’s immunotherapy knowledge.

The alliance will emphasize three areas:

  • Original drug design: BioNTech is advancing mRNA-based vaccines (most notably with Pfizer, as they work towardsa coronavirus vaccine) and therapeutics, and will use InstaDeep’s DeepChain protein design platform to design new mRNA sequences for protein targets, including for its RiboMab and RiboCytokine platforms, which use mRNA to encode antibodies and cytokines in vivo.
  • Innovative analytics: Both companies plan to receive insights from public and proprietary meta datasets, along with anonymized patient data through the use of ML and edge analytics.
  • Manufacturing and supply chain optimization: BioNTech will use AI and ML applications to further expand upon manufacturing and supply chain processes.

Ugur Sahin, MD, CEO and co-founder of BioNTech, sees this as an ideal time to further grow in the immunotherapy market through opportunities in advanced digitalization.

“We see a significant opportunity at the intersection of AI and immunology by computational design of new precision immunotherapies,” he explained. “This collaboration will expand our digital capabilities and optimize our operations across the value chain. We look forward to working with InstaDeep to advance the next wave of innovation in the field.”

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CCT dedicates new facility to dispensing Covid-19 vaccine

Cold Chain Technologies (CCT), a company that is no stranger to innovation, has opened up a new location in Lebanon, TN, a 255,000 sq.-ft. cold chain facility that’s main priority will be Covid-19 vaccine distribution.

The space contains Koolit refrigerant manufacturing and work cells for CCT’s KoolTemp EcoFlex (CCT’s reusable thermal packaging solution), with the capability to support the coronavirus’s temperature-sensitive supply chain stipulations.

With 50-plus years of operation, CCT’s CEO, Ranjeet Banerjee, contends the company is up to the tall order that lies ahead, and scaling up to meet critical needs during Covid-19. “Our longstanding history and partnerships through previous pandemics, coupled with our deep engineering and testing lab capabilities, position us to tackle this Covid challenge,” he said. “Our packaging solutions will help ensure the integrity of these vaccines during transit and enable the safe delivery of vaccinations.”

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DHL further propels investment in San Juan facility

DHL Global Forwarding is growing its 72,000 sq.-ft. certified life science station in San Juan, Puerto Rico by investing over $650,000 in further cold storage space and technology for the life sciences and healthcare sector. This comes after previously announcing its $70 million US life sciences investment earlier this year, and the completion of a $1.6 million Indianapolis facility.

When it comes to working with Puerto Rico—which has been looking to fill a US supply chain gap—relations date back to 2016, when DHL funded over $1 million to reaching a tenfold upsurge in its temperature control area capacity. The latest announcement expands on that goal.

Among the various highlights, the mail service’s new project will consist of:

  • Construction of a new deep-frozen cool room with a temperature range of -18.0 to -30.0 °C, which allows for pre-conditioning of passive containers, blankets, boxes and PCM units, while still providing full ability to provide product delivery.
  • Additional 2-8 °C storage, a temperature controlled cross docking area and ample space for the control of RAP containers, which can each fit four US-size pallets.
  • Supplementary loading and unloading services for containers under the controlled ambient temperature (15-25°C & 2-8°C).

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Amazon Pharmacy is here; will it change the retail drug business?

It is probable that Amazon’s Nov. 16 announcement of the long-awaited Amazon Pharmacy has had a bigger impact on Wall Street than in drug distribution, at least for now. The day of the announcement, the prices of the leading chain pharmacies dropped by 6-10%, and the Big 3 wholesalers by 1-2.5%. Amazon’s entry into pharmacy services has been a fixation of market analysts for over two years—ever since it acquired PillPack, a mail-order pharmacy that packages multiple drugs in pouches for polypharmacy patients, for $700 million—and back then chain pharmacies and major wholesalers also took a financial hit. Market watchers expect Amazon Pharmacy to be an e-commerce disrupter, as it has been for so many other retail industries.

The initial assessment of the Amazon announcement, however, is less dramatic. For one thing, retail pharmacies have by and large already adopted one of Amazon’s basic consumer benefits—home delivery in one or two days. At the same time, mail-order pharmacy has been a longstanding component of the pharmacy business, representing over a quarter of the market by sales. In its announcement, Amazon noted that it will be working with InsideRx, a business unit of Cigna (which is also the owner of the pharmacy benefit manager Express Scripts) to provide drug discounts that are potentially better than an insurer’s price (for those consumers on commercial insurance), as well as offering lower prices to the uninsured (cash) drug purchaser.

These discount programs are already available to consumers via other marketing programs—so, in the end, it will become the same sort of comparison shopping that consumers perform with many of their other purchasing decisions. Amazon noted that it will not share protected health information of its customers with others (without customer permission); however, this opens up the intriguing question of whether customers whose non-prescription purchases (of, say, glucose test strips used by diabetics) will be exposed to pharmaceutical marketing by the company.

There has been a buzz around Amazon for its potential in providing a range of health and wellness services, a trend that retail pharmacies, health systems, and a host of Silicon Valley startups have been looking at for the past few years. With a built-out pharmacy offering, Amazon takes a step closer to being a major player in healthcare. (One analyst even speculated that Amazon could co-locate a brick-and-mortar pharmacy in its Whole Foods stores, just as other supermarket chains have done.) But this big-picture view will take years to play out.

What effect does Amazon Pharmacy have on the pharma industry? For now, not much, beyond adding another retailer to the retail pharmacy channel. If it chooses to continue to go after the healthcare business, though, more changes might be coming from the company.

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Pharma tech developer increases UNC Health’s footprint

Arxium, a provider of automation, workflow and inventory management solutions who over three years ago added upgraded software to its RIVA pharmacy-compounding system, has completed a multi-year process that expands and integrates the UNC Health Shared Services Center, UNC Hospitals and Rex Hospital.

UNC Health utilizes RxWorks Pro, a supply management application which during Covid-19, has been helpful in providing available quantity on hand (QOH) information. It lets the informatics department remotely access RxWorks, enabling the health system to share QOH data for specific medications, such as remdesivir. The app’s virtual location feature helps manage Covid-related medication stock across all UNC facilities and provides real-time tracking and optimization of locations that experience the most demand.

Dr. Niels Erik Hansen, president and CEO of Arxium, observes that the battle against Covid-19 has been a difficult one, but it has reminded everyone of the need for logistical organization and the value of backlog analysis.

“ … While COVID presented unforeseen challenges,” he said, “it demonstrated a renewed importance of inventory management due to supply chain disruptions and other issues. As such, our mobile application has served as a timely solution for efficiently managing UNC’s Covid-related supplies.”

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Pharma Logistics and ConsortiEX join forces to foster supply chains

Pharma Logistics, a service provider operating out of its new Illinois-based reverse-distribution center, and ConsortiEX, a health care pharmacy IT company in Wisconsin, launched a strategic collaboration program, whose aim is to improve inventory efficiency and patient safety, reduce cost, manage cash flow and compliance for their customers.

Highlights of the program include:

  • ConsortiEX’s Drug Supply Chain Security Act (DSCSA) compliance takes responsibility for a majority of the work necessary, helping provide a lower cost.
  • Pharma Logistics’ reverse distribution service not only speeds up the process of returning generated credits—it also keeps labor costs for managing those returns at a minimum.
  • ConsortiEX’s services look to provide the most effective way of detecting suspicious drugs, so that these products do not reach the patients.
  • If saleable, unsaleable and recalled drugs need to be returned, Pharma Logistics works to simplify the credit recovery process.

Customers working with both companies will be able to use funds from Pharma Logistics to pay for ConsortiEX resources. And down the road, the organizations plan on assisting their mutual clients by managing drug recalls, optimizing inventory levels and limiting waste by keeping track of items that are close to expiring.

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New IATA recommendations outline coronavirus vaccine distribution plan

The International Air Transport Association (IATA), which previously noted that month-on-month global demand for air cargo in September increased 3.7% over August numbers, recently released logistics supply chain guidance to help make sure that the air cargo industry is ready to support the handling, transportation and distribution of a Covid-19 vaccine.

Produced with the backing of various partners, such as the International Civil Aviation Organization (ICAO), International Federation of Freight Forwarders Associations (FIATA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pan American Health Organization (PAHO), UK Civil Aviation Authority, World Bank, World Customs Organization (WCO) and World Trade Organization (WTO), IATA’s Guidance for Vaccine and Pharmaceutical Logistics and Distribution consists of myriad international standards and guidelines related to the transport of vaccines, being revised as frequently as information is made available.

The association, as reported by AviationPros, references several notable obstacles, including:

  • The availability of temperature-controlled storage facilities, including alternatives when these are not accessible.
  • Defining the roles and responsibilities of everyone involved in vaccine distribution, such as government authorities and non-governmental organizations (NGOs).
  • Industry readiness for vaccine distribution, which includes: capacity and connectivity; facilities and infrastructure (availability of the proper temperature-controlled facilities and equipment and staff trained to handle time- and temperature-sensitive vaccines); border management (receiving proper clearance and landing permits) and security.

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Catalent-cell therapy manufacturer deal now complete

Following an agreement Pharmaceutical Commerce originally reported being reached in late October, Catalent Pharma Solutions, Inc. has officially completed its acquisition of Bone Therapeutics’ manufacturing subsidiary, Skeletal Cell Therapy Support SA (SCTS), for $14.2 million USD ($12 million EUR). With the transaction closing, SCTS’ manufacturing infrastructure and production operating teams are now part of Catalent’s Cell & Gene Therapy division.

Alongside this deal, Bone Therapeutics and Catalent also entered into associated supply agreements, which state that the purchased manufacturing entity will continue to service the production of ALLOB, Bone Therapeutics’ allogeneic cell therapy product, for Bone Therapeutics and its partners. This will grant the company access to Catalent’s network of clinical and commercial manufacturing facilities.

The partnership will allow Bone Therapeutics to focus its strategy on product development from its MSC (mesenchymal stromal cell) platform of cell and gene therapeutic targets for orthopedics, among other indications.

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CCA debuts change management matrix

With a potential inoculation on the horizon, the Cool Chain Association (CCA) has launched a Covid-19 Distribution Change Management Matrix. Its objective: supporting airports with their coronavirus vaccine logistics plans.

As noted by AviationPros, the matrix examines adherence to temperature requirements, packaging, forecast and quantity and timeframe across different stages in a vaccine’s journey through an airport—this is different than the initiative launched by Worldwide Flight Services (WFS), known as “Project Coldstream,” which determines how to efficiently transport large volumes of Covid-19 vaccines.

CCA will look to share the matrix with members for them to fill out. From there, the information will be combined to assist the supply chain in determining focal points, such as training needs, safety and security, as well as supplier and risk management.

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Antares Vision Strengthens Traceability Position

Italian multinational Antares Vision, which offers customized inspection and track-and-trace systems, has been selected by the French judicial authority as the winner of the tender for the purchase—directly or indirectly through its subsidiaries—of the assets of the French company Adents High Tech International, which is in liquidation. The closing will occur within two months for $1.8 million USD (1.5 million EUR), paid in cash.

Mainly focused on the pharmaceutical sector, Adents offers traceability and serialization software that can be used for the data management and exchange between companies and regulatory authorities (level 5). It also offers single-tenant and multi-tenant cloud services.

The deal lets Antares Vision multiply its software capabilities that are able to track and trace the end-to-end supply chain, which will allow for greater transparency among members across the industry. Both companies have verification router service (VRS) offerings.

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UK’s Envision lands launch expert Two Labs

Envision Pharma Group, a UK-based scientific communications company, has acquired Two Labs, a strategic consulting and commercialization provider with a footprint in the US pharma domestic market. Two Labs is known for helping pharma companies develop and execute customized launch strategies for products, a process that may include selecting a third-party logistics provider (3PL).

Howard Miller, CEO, Two Labs, noted, “We are delighted to be joining the Envision family and taking Two Labs to the next logical step in its successful journey to date. With Envision’s global footprint and Two Labs’ market-leading US footprint, we have a unique opportunity to enrich our client partnerships with more connected services across the launch continuum.”

He pointed as well to a “compelling” cultural fit between the two organizations.

Envision’s acquisition of Two Labs follows the recent announcement of GHO Capital’s increased investment in the company and management support for its continued expansion. Since its inception in 2001, Envision has produced solid organic growth, while also providing medical affairs strategy, medical communications, and its iEnvision technology.

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Pfizer’s Covid-19 vaccine could present cold-chain concerns

In news reported by Reuters on Tuesday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus indicated that it hopes to have a Covid-19 vaccine by end of 2020 and that Pfizer’s experimental candidate is “a very promising one.”

However, vaccines such as Pfizer’s that use synthetic mRNA to activate the immune system against the virus have to be stored at -70 ºC (-94 ºF) or below, which could be more complicated in places with warmer climates, such as Africa and Asia, where the proper equipment to handle these temperatures may not be up to par, the report notes.

From a logistical standpoint, this also raises the question of how the product will be safely transported, as recent surveys indicate that the air cargo industry feels unprepared for such a challenge. However, that does not necessarily signify that a cold chain cannot still formulate a successful plan to meet the forthcoming demands.

Pfizer, which will be coordinating its own vaccine distribution, made headlines earlier this week after revealing that its vaccine, jointly developed with BioNTech SE, was over 90% effective, according to the first set of interim data from a large-scale clinical trial.

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J. Knipper completes acquisition of Eagle Pharmacy

J. Knipper and Company, Inc., a supplier of pharma healthcare marketing services, and its affiliates (including its three-year-old specialty pharmacy, KnippeRx), have finalized the acquisition of Eagle Pharmacy, LLC, a full-service, direct-to-patient (DTP) pharmacy. KnippeRx and Eagle Pharmacy are approved to ship and dispense prescription medications throughout the US, the District of Columbia and US territories.

Florida-based Eagle Pharmacy adds operational automation and scalability to KnippeRx’s résumé, while simultaneously offering clients separation of customer pharmacy solutions under one partner. According to J. Knipper, over 90% of enrollments completed by Eagle result in a shipment, while clean orders are processed and shipped in less than one business day. Operations are currently at 25% capacity, but Eagle Pharmacy reaches approximately 200,000 patients a month, supporting more than 50 customized drug programs.

KnippeRx, a provider of patient assistance program (PAP) services, has seen rapid expansion, adding brand name, DTP programs to its pharma client offerings, among pursuing other avenues for evolution.

J. Knipper previously underwent an ownership change in October 2019 after 33 years as a family business.

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Descartes expands last-mile delivery presence

Descartes Systems Group, a supply chain software firm that offers its technology to the pharmaceutical space, has purchased ShipTrack, a Canada-based provider of e-commerce final-mile (last-mile) solutions for $19 million.

ShipTrack offers cloud-based mobile resource management and shipment tracking solutions. These tools are able to assist users with automating dispatch, updates on shipment status and estimated time of arrival (ETA); they also remove the need for paper-based delivery. ShipTrack notes that its platform is a fit for the medical courier market—one component of the growing last-mile delivery market, which reports estimate to reach about $6.2 billion by 2025.

Shawn Winter, co-founder of ShipTrack and now the vice president of mobility solutions at Descartes, alluded to the obstacles surrounding high demand that are often faced by last-mile delivery services, saying that “The challenge for today’s final-mile carriers is how to handle increasing volumes alongside rising consumer expectations for delivery choice and real-time information. Our platform helps final-mile carriers meet that challenge head-on with powerful workflows across delivery processes and the ability to expose information to consumers in real-time.”

He says the deal merges ShipTrack’s final mile know-how with Descartes’ ability to improve routes.

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Progress on DSCSA compliance slows down in US pharma supply chain

The US pharmaceutical supply chain progressed by fits and starts during 2020 in its quest to enable end-to-end traceability along with compliance with the Drug Supply Chain Security Act (DSCSA). Clearly, the ongoing global pandemic has had a retarding effect—supply chain managers’ top priority these days is preparing for the coming wave of Covid-19 vaccine shipments. But other factors—technical, organizational and political—are having an effect as well.

Data from the 2020 Serialization Readiness Survey, released by the Healthcare Distribution Alliance Research Foundation, revealed that only 21% of manufacturers polled plan to send serialized data with 100% of products in 2020, a decrease from last year’s survey. Adoption of aggregation—the technical need to link serial data on individual packages with the cases or pallets in which they are shipped—is at something of a standstill: in last year’s survey, more than half of manufacturers (56%) noted that they planned to aggregate by 2019. “The same number responded that they plan to aggregate by the end of 2020, indicating there has not been much additional progress over the past year,” notes the report. “The number of manufacturers who plan to aggregate by 2023 is down to a quarter from a third, indicating other companies have shifted their timelines up and will aggregate between now and then.”

The survey was conducted over the summer (even as the industry was scrambling to address the pandemic), and was part of the reason that FDA recently announced an enforcement delay in meeting the DSCSA requirement of verifying the integrity of returned products returned to wholesalers by Nov. 27. That deadline has now been pushed to November 2023, which is when the entire “enhanced drug distribution security” framework of DSCSA is to be in place. A limitation of the survey data is that it is based only 57 manufacturers, and it’s not clear that the same respondents in 2019 participated in 2020.

“While DSCSA implementation is still a high priority for the pharmaceutical supply chain, we can see an industry adapting and adjusting to support patients and frontline healthcare providers during the COVID-19 response,” said Perry Fri, EVP, industry relations at HDA.

VRS and EPCIS

A key enabler of verifying returned product at the wholesaler has been the Verification Router Service (VRS), a system voluntarily set up among wholesalers and many of the leading IT providers of DSCSA-compliant software. From late 2019 to mid-2020, providers and wholesalers were testing the ability to link the VRS of one provider to others, so that product verification queries could be directed to the correct manufacturer.

According to the HDA survey, 49% of manufacturers “had concerns” about their own ability to support verification requests. Among wholesalers, only 4.8% of respondents felt that dispensers (i.e., retail pharmacies) understood the latters’ DSCSA responsibilities; 47.6% of wholesalers had concerns about their own capabilities. These findings were among the reasons that HDA, together with the American Pharmacists Assn. and others, successfully petitioned FDA to postpone the November 2020 deadlines.

A similar insufficiency exists with EPCIS, an acronym representing the protocol for communicating product data among trading partners. Although most manufacturers use some version of this protocol, and most distributors are equipped to receive EPCIS data, only a fraction of both are doing so currently. (EPCIS is not a requirement of DSCSA, now or in 2023; however, nearly everyone in the supply chain believes that some agreed-on standard is essential to making the entire program work.)

Cross border

While attendees of this year’s HDA Traceability Seminar (online, Nov. 2-4) were mulling over these technical issues, some part of their attention was focused on the Trump administration plan to allow imports of pharmaceuticals from abroad, which sidestep the structure of the domestic supply chain and flies in the face of the security concerns that led to the DSCSA’s passage. This “reimportation” has been touted as a cost savings to the US healthcare purchaser (whether a patient or a state health fund), although the savings are in doubt.

A final rule was issued in late September, and on Oct. 1, FDA provided a guidance document for its implementation. Florida was a leading state seeking to set up an importation program, but according to Kaiser Health News, no vendor had answered the state’s RFP as yet. Vermont, Colorado, Maine, New Hampshire and New Mexico are other states that have signaled intentions to set up programs as well.

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September air freight experiences growth

Month-on-month global demand for air cargo in September increased 3.7% over August numbers, according to the most recent data from the International Air Transport Association (IATA). However, demand, which is measured in cargo tonne-kilometers (CTKs), was actually 8% below September 2019’s numbers, but an amount that is still a step above the 12.1% year-on-year drop recorded in August.

Alexandre de Juniac, IATA’s director general and CEO, noted the industry struggles but approached it with a glass-half-full mentality, stating  that “Air cargo volumes are down on 2019, but they are a world apart from the extreme difficulties in the passenger business. For air cargo, 92% of the business is still there, whereas about 90% of international passenger traffic has disappeared. Favorable indicators for the peak year-end season will support the continued recovery in demand.”

The association’s CEO also referenced the ongoing challenge that capacity poses during the coronavirus pandemic, as carriers will need to modify schedules to mirror the decrease in demand.

The aforementioned global capacity, measured via available CTKs, shrank by 25.2% for the month of September and 28% for international operations, compared to 2019. That makes it almost three times greater than the contraction in demand.

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Puerto Rico is poised for a greater supply chain role

OPINION

The novel coronavirus has challenged the notion that our US supply chains were prepared, exposing limited logistics models, shuttering manufacturing lines, and causing personal protection and medical equipment shortages worldwide. Reliance on other global powers has become a national security concern and prompted a push to reshore life-critical manufacturing.

Puerto Rico is at the front and center of this movement. With a wealth of industry expertise, talent, and R&D prowess, the island is well-positioned to continue building on these strengths and affirm its spot as a global contributor. Puerto Rico can be a solution to filling critical supply chain and emerging gaps in the medical fields.

Talent, as mentioned, is a key driver. Compared to the US national averages, the territory boasts 8.6 times the pharmaceutical experts and 5.3 times the amount on the medical device end; for scientists and engineers across all fields, Puerto Rico has the sixth-largest concentration in the world. It also graduates 26,000 STEM-focused university students a year, which accounts for 60% of all graduates.

Puerto Rico was granted a waiver in May to open its airport capacity to increased passenger and cargo transfer abilities. This positions the island as a key transport hub for the US and, moreover, the Western Hemisphere, serving as a connector to other major global markets (e.g., Europe, Africa).

The island’s swift response to the initial wave of COVID-19 in March came instinctively, given past experiences with natural disasters, and it prompted industry to continue its manufacturing output. When Puerto Rico faced back-to-back hurricanes in September 2017, it still reportedly outperformed mainland states in total pharmaceutical exports. This year, several manufacturers claimed zero downtime in shift operations during the January earthquake.

With federal agencies eyeing domestic supply chain support for critical drug manufacturing, Puerto Rico is working with companies seeking financial incentives and loan opportunities so that they clearly understand the“why us?” The five reasons driving that message are:

  1. Site-ready. With 50+ bioscience site-ready facilities and properties at all stages of development ready for occupation, the lead time on getting production going in Puerto Rico is faster than any other location.
  2. Local supply and distribution chain. Dedicated Puerto Rico-based businesses and industry organizations are equipped with the background and skills necessary to support the bioscience industry’s needs.
  3. Expertise and workforce. From mapping out the first continuous manufacturing model in the world to supporting other countries (Ireland and Singapore) in building their own bases, Puerto Rico shares the wealth and knowledge with other pharma markets.
  4. Resources. Puerto Rico is working in close collaboration with the Development Finance Corporation and other federal agencies, in addition to the private sector, on creating competitive tax incentives and financing packages best suited for prospects seeking to reshore.
  5. Continuously innovating. Aside from the biosciences industry, the island is investing in renewable energy solutions, advanced connectivity, and transportation, among other entrepreneurial initiatives.

This is a historic moment for Puerto to solidify its place in the US medical supply chain and serve as a base for key drug and medical device manufacturing, while creating new opportunities for its workforce and the larger biopharma industry.

 

About the author

Gail T. Nolan is chief strategy officer of Invest Puerto Rico.

 

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UK schedule for Covid vaccine delivery falls behind

Per a report by Reuters, the timetable for delivery of the Oxford University/AstraZeneca Covid-19 vaccine candidate (AZD1222, ChAdOx1 nCoV-19) has slipped. UK vaccine chief Kate Bingham, according to the report, said that Britain will receive just four million doses of the shot this year. As this Lancet article and a separate Reuters report explain, the vaccine is made from a weakened version of a common cold virus that causes infections in chimpanzees—the chimpanzee cold virus has been genetically modified to include the genetic sequence of the  spike protein, which SARS-CoV-2, the novel coronavirus that causes COVID-19, travels on to enter human cells. 

In May, Britain agreed to take 100 million doses of the vaccine, with 30 million doses originally estimated for delivery by September, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said that clinical trials of the vaccine candidate were safe to continue. Across the pond, the FDA authorized a trial restart in late October. The exact timing for delivery is uncertain at this point, as it depends on infection numbers.

Bingham, Reuters reports, said that the vaccine was being made initially in bulk (drug substance) but could not yet be transferred into vials until more certainties of the timing of late-stage trial data delivery. She added that once the vaccine is put in vials, the clock for shelf life—and how soon one can use the product—begins.

AZ, in a written statement to Reuters, indicated it was making progress to start supplying hundreds of millions of doses on a rolling basis once it receives regulatory approvals. The Oxford/AZ candidate is likely to be among the first vaccines from big pharma to be submitted for governmental authorization.

For an overall look at the regulatory picture for Covid-19 vaccines, read Pharmaceutical Commerce‘s chat with Dr. Ash Ramzan of Woodley BioReg Ltd.

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New application streamlines serialization techniques

TraceLink, a Massachusetts-based digital platform company for the life science supply chain, officially introduced Serialized Product Intelligence, a new cloud application that uses serialization data to simplify the process of managing data across companies’ operations. The software provider previously set the table for this program last year after introducing its Digital Network Platform (DNP), which allows users to “rapidly design and deploy network orchestration and analytics applications, enabling patient-centric orchestration.”

According to TraceLink, biopharma companies can proactively monitor serialized operations, identify supply chain issues early, avoid costly delays and maintain timely product delivery to market. It could serve, TraceLink contends, as a first step in building a foundation for using more advanced technologies to predict and prevent critical business issues from occurring.

Serialized Product Intelligence is a fully automated, self-service analytics application, built on TraceLink’s Opus DNP, which the company says is the only such platform designed to support the development of multi-enterprise business applications for the pharma industry.

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Pact struck around thin-film freezing tech for Covid-targeted mAbs

TFF Pharmaceuticals, Inc., a clinical-stage biopharma that recently increased its cGMP capabilities, and Augmenta Bioworks, Inc., a biotech that uses immune profiling technologies for medicinal purposes, have entered into a joint development and collaboration agreement to develop products incorporating Augmenta’s human-derived monoclonal antibodies (mAbs) for potential Covid-19 therapeutics. Previously, in June, the companies struck a feasibility and material transfer agreement under which Augmenta supplied various mAb product materials to TFF for compatibility and feasibility testing.

Per the most recent agreement, both companies will collaborate to develop one or more commercial therapeutics based on, derived from and/or incorporating Augmenta’s human mAbs to potentially treat patients with Covid-19. These products will be developed using TFF’s thin-film freezing technology to manufacture dry powder formulations of these specific mAbs for inhalation delivery directly to patients’ lungs.

Further, the agreement includes the development of formulations suitable for parenteral administration, where the thin-film freezing dry powder formulations can be reconstituted, potentially mitigating the impacts of cold-chain storage and handling. TFF will also have the option to develop two additional Augmenta mAbs for indications other than Covid-19.

Robert O. Williams III, PhD, division head of the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery and inventor of TFF’s thin-film freezing technology, said a challenge of mAbs is in their delivery via injection, which does not reach directly to the initial site of infection—the deep lung area. “Liquid injections are also subject to all the attendant difficulties of cold chain handling and storage, potentially limiting their use to only areas in the developed world,” noted Williams.

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Pfizer to coordinate its own coronavirus vaccine distribution

According to a published report by FreightWaves, pharma giant Pfizer will manage the distribution of its Covid-19 vaccine on its own instead of through the US government’s designated coordinator, McKesson. In July, the US government reached a contractual agreement with Pfizer to deliver 100 million initial doses once its vaccine is approved, along with an option for an additional 500 million doses. Pfizer’s vaccine must be kept at minus 75 ºC (-109.3 ºF) to maintain its effectiveness, FreightWaves notes.

Officials, according to the report, said they expect to provide safety data from Pfizer’s final-stage clinical trials to FDA by the third week of November and, subsequently, apply for an emergency use authorization if all goes well, But there is also skepticism, the report says, concerning whether the US has enough medical-grade freezers at the point of use for vaccines requiring storage at ultra-cold temperatures.

“The responsibility for determining how many deep-freeze machines exist at healthcare facilities has fallen on states because there is no central inventory,” FreightWave’s Eric Kulisch writes. He notes that uncertainty about the cold-chain capabilities of transportation providers and vaccine administration facilities resulted in Pfizer developing a special cooler, or “thermal shipper,” with real-time GPS and thermal monitoring that can maintain deep-freeze vaccine storage for 10 days if left unopened. Kulisch reports that the shipping container is “about the size of a small suitcase” and uses dry ice to maintain recommended storage temperatures.

In mid-August, as reported here, the Centers for Disease Control and Prevention (CDC) designated Irving, TX-based McKesson as the “centralized” distributor of future Covid-19 vaccines. Pharma manufacturers will ship approved vaccines to McKesson distribution centers, which, in turn, will disperse to hospitals, nursing homes, and other points of care.

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New HDA Research Foundation survey points to positivity for pharma supply chain

A survey released yesterday by the Healthcare Distribution Alliance (HDA) Research Foundation suggests that, overall, the pharmaceutical supply chain continues to make steady progress to comply with the 2013 Drug Supply Chain Security Act (DSCSA).

Back in April, the FDA made a DSCSA announcement that would help expedite drug deliveries from suppliers to where they were needed by suspending some distributor requirements; however, some implementation priorities have shifted amid the initial industry response to the Covid-19 pandemic.

HDA’s new “Serialization Readiness Survey  determines the current preparedness of manufacturers and distributors to meet DSCSA requirements, when distributors can expect to begin receiving serialized product, as well as perceptions of dispenser readiness. Survey responses were collected prior to FDA’s announcement of additional enforcement discretion related to certain DSCSA dispenser and wholesale distributor requirements. The agency is now permitting until Nov. 27, 2023, for compliance.

Data reflect the survey responses of 57 manufacturers—including 14 of the 2018 top 20 pharmaceutical manufacturers by sales and nine of the top 20 manufacturers by prescriptions dispensed as listed by IQVIA—and 21 distributors. Among the findings:

  • Nearly half of manufacturers and distributors note challenges with the requirement for industry to process serialized saleable returns. Covid-19 was cited as a reason for this response, as gaining entry to company facilities has impacted the ability to train employees and implement systems as planned.
  • Approximately 5% of distributors believe that their dispenser customers understand what is required of them for overall DSCSA compliance. Moreover, nearly two-thirds (62%) of wholesale distributors report dispenser knowledge of DSCSA requirements varies considerably among pharmacy industry segments.
  • About 21% of manufacturers plan to send serialized data with 100% of products in 2020, a decrease from last year’s survey. While a majority anticipate sending 100% of data with shipped product by 2023, when it is legally required, 32% plan to first send data between 2020 and 2021, resulting in more than half of manufacturers sending data for at least some products by the end of next year.
  • Collectively, manufacturers and distributors cited collaborating with trading partners, governance, differing legal interpretations of the DSCSA and establishing standards as priorities as the industry moves toward 2023 interoperability.

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Sonoco ThermoSafe strengthens presence in ULD sector

Sonoco ThermoSafe, a temperature assurance packaging company, and AirBridge Cargo Airlines have signed a master lease agreement to offer Sonoco ThermoSafe’s new Pegasus unit load device (ULD) bulk temperature-controlled container directly to its customers.

The Pegasus ULD. Credit: Sonoco ThermoSafe

This comes after the Pegasus ULD creator reached a development and manufacturing partnership with AeroTuf last year. The device uses AeroTuf’s patented Aerotherm composite material technology.

Pegasus ULD is also the first passive bulk temperature-controlled container approved for pharmaceutical use. Its FAA clearance, Sonoco ThermoSafe says, allows the device to speed through existing international ground handling and customs processes at the lowest possible cost.

With the composite-material engineering, Pegasus offers a lighter solution that is described as “substantially more damage resistant than traditional metal containers.” It also contains a fully integrated, FAA-approved telemetry system. The system, the company says, provides real-time, cloud-based data on payload and ambient temperature and environmental factors, synchronized with GPS location.

AirBridgeCargo Airlines, part of Volga-Dnepr Group, is the largest Russian cargo airline. It operates scheduled cargo services on routes between Russia, Asia, Europe and North America.

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Key certification for cargo company’s Covid vaccine preparations

FCS Frankfurt Cargo Services was recently granted EU good distribution practice (GDP) certification for medical products for human use—a key step in the company’s goal to expand its pharmaceutical logistics activities and ramp up preparations to handle sensitive Covid-19 vaccine consignments.

This designation comes on the heels of FCS concluding its International Air Transport Association (IATA) Center of Excellence for Independent Validators (CEIV) certification—one that airport hubs consisting of air cargo carriers, ground handlers and freight forwarders operating at the hub are able to receive collectively.

FCS Frankfurt Cargo Services in Frankfurt, Germany. Credit: FCS Frankfurt Cargo Services

Unlike CEIV certification, which relates exclusively to airfreight, GDP certification stands alone. It involves checking the quality of the distribution chain for medical goods and ensuring that they are intact, from from the producer to the end customer, according to EU standards.

A subsidiary of Worldwide Flight Services (WFS), an airfreight handling company, FCS and its GDP certification fit into the “Project Coldstream” initiative recently launched by WFS, which focuses on coordinating worldwide transportation of large delivery quantities of vaccines to fight Covid-19. According to the IATA, the industry expects these deliveries to amount to the largest volume of airfreight involving a single item ever transported.

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Onfleet raises $14M in Series A funding for last-mile delivery services

Onfleet, a provider of last-mile delivery management software, has raised $14 million in Series A funding to meet rising customer demand.

According to the San Francisco-based company, it added hundreds of new customers this year and has doubled its year-over-year overall delivery volume, as COVID-19 has rapidly accelerated retail’s transition to online, delivery-centric models. The company says it has powered more than 80 million deliveries to over 90 countries for clients including several pharmacies. This investment round brings Onfleet’s total funding raised to $20 million since inception.

The company’s routing and dispatch platform allows for real-time communications and delivery management. Particularly amid the continuing global COVID-19 pandemic, there has been increasing attention paid to last-mile logistics in the pharma supply chain, and the use of new technology to expand care access in remote areas.

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Survey: Technology and drug pricing clarity key to industry recovery

Proposed moves aimed at gaining ‘most-favored nation’ drug pricing so that Medicare pays the same drug prices as other developed countries would face significant barriers to implementation, according to results of a survey released this week by Model N, Inc., a technology provider for many large pharma companies.

Model N fielded its survey to more than 100 pharmaceutical and medtech professionals in July 2020 in order to understand more about key financial concerns, public-facing issues associated with drug pricing, attitudes around technology, and to gauge the industry’s response to the global coronavirus pandemic.

Results indicated that a program requiring an overhaul of today’s complex system of incentives and rebates, as well as initiatives designed to address the technological and regulatory constraints under which the industry currently operates, would face an uphill battle.

Some 86 percent of the respondents believe there is a disconnect between pharmaceutical companies and the general public when it comes to the perception of drug pricing. The top reason cited (76 percent) was a lack of understanding of the complexity behind how a drug is paid for and how it gets to patients.

Other reasons cited by survey respondents include pricing disparity and international pricing differences (46 percent) and government regulations (46 percent).

Pharmaceutical and medtech executives also have concerns over revenue issues, with the survey showing that government regulations, as well as pricing and rebates, are the top concerns for solving revenue problems, at 41 percent each. While only 9 percent said Covid-19 has not impacted their revenue this year, 46 percent reported that it has impacted their revenue by delaying the process of bringing new products to market.

There is awareness that technology is key to solving the issues, as some 67 percent believe their companies need to invest more in technology to solve their financial and revenue management challenges.

In addition, the executives seem open to exploring new approaches to resolving revenue concerns, while at the same time addressing public concerns about drug prices. They cite better management of government regulations (26 percent), as well as pricing and contract compliance (25 percent), as two key opportunities for fixing pricing issues and avoiding ‘leaving money on the table.’ Assistance with value-based pricing is another area where industry professionals think technology can offer a useful assist, at 44 percent.

When polled about a broader, post-pandemic recovery, 76 percent of respondents report they have been satisfied with the industry’s response to Covid-19. Some 49 percent emphasized recovering from Covid-19 as their top priority, while 45 percent said eliminating system or process inefficiencies was their biggest priority for the remainder of 2020.

Overall, 40 percent said technology will be a key enabler in helping their firms recover from Covid-19. In terms of corporate planning, 55 percent of respondents report that current or new product launches are the top priority for the remainder of this year.

Model N offers visibility, insight and control for complex commercial operations and compliance, along with cloud revenue management technology in order to automate pricing, incentive and contract decisions. It serves such major pharmaceutical, medical technology, semiconductor and high-tech companies as Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom and Microchip Technology.

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Schreiner MediPharm equips Cap-Lock security label with RFID technology

Schreiner MediPharm, a Germany-based provider of functional labels for the healthcare industry, has augmented its Cap-Lock tamper-evident specialty label with an RFID inlay.

Cap-Lock label now equipped with RFID inlay. (Credit: Schreiner MediPharm)

Developed to expand digitization initiatives at hospitals, the label-and-cap security concept for prefilled syringes now enables automated inventory and supply chain management, as well as digital first-opening indication. In doing so, the new Cap-Lock plus RFID offers product authentication and enhanced patient safety.

Equipping syringes containing liquid medications with RFID labels poses a challenge, as both the container material and the composition of the liquid may impair reading of a UHF RFID label. Flag labels protruding from the container are frequently used for this purpose; however, these typically require additional space, are prone to being torn off and must be applied manually.

With the enhanced Cap-Lock, the RFID chip is integrated within the label, which wraps around the syringe body and cap adapter and, once opened, provides irreversible tamper evidence due to an integrated perforation.

The RFID inlay is located in the upper part of the label at the level of the cap. It mostly sits outside the liquid-filled area and enables long-range reading. The label can be automatically processed as part of the primary container’s normal labeling workflow, according to the company.

Schreiner MediPharm’s US facility is located in Blauvelt, NY.

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Catalent to acquire cell therapy manufacturing facility in Belgium

Catalent has signed an agreement with Bone Therapeutics to acquire its cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support SA, including all of its assets located in Gosselies, Belgium. The transaction is expected to close in November.

The Skeletal Cell Therapy Support manufacturing facility in Gosselies, Belgium. (Image courtesy of Catalent)

Under the terms of the agreement, Catalent will purchase the shares of Skeletal Cell Therapy Support, currently held by Bone Therapeutics, which owns and operates a purpose-built CGxP facility of approximately 41,000 square feet, including its related quality control and product development laboratories, warehouse, grade C and B cleanrooms and equipment, as well as land for further development.

Catalent will undertake the manufacturing of clinical material for Bone Therapeutics’ drug, ALLOB, an allogeneic osteoblastic cell therapy product, derived from ex vivo cultured bone marrow cells.

The Bone Therapeutics subsidiary and its facility, which is next to Catalent’s existing cell therapy site, will allow Catalent to expand its cell therapy capabilities and advanced clinical and commercial supply. Catalent is continuing work on a 60,000-square-foot commercial-scale production and fill-finish facility in Gosselies, which is scheduled to be completed by the end of 2021.

As part of the acquisition, manufacturing employees located in Gosselies and employed by Skeletal Cell Therapy Support are expected to remain with that entity and become part of the Catalent workforce, and Bone Therapeutics will continue to focus on its pipeline of products for orthopedics and bone diseases.

In addition to the expansion in Gosselies, validation of Catalent’s new 32,000-square-foot cell therapy development facility in Houston, TX is underway and scheduled to be completed by the end of this year.

Bone Therapeutics has a diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Catalent, based in Somerset, NJ, provides delivery technologies, development, and manufacturing services for drugs, biologics, cell and gene therapies, and consumer health products. Catalent employs approximately 14,000 workers, including roughly 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated more than $3 billion in annual revenue.

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US biopharmaceutical supply chain resilient and effective during early Covid-19 response

A new report published by the Healthcare Distribution Alliance (HDA) Research Foundation and Deloitte Consulting LLP found that during the first 90 days of the Covid-19 pandemic, the biopharmaceutical finished goods industry adapted and adjusted to deliver medicines safely and efficiently to patients with only minimal disruptions.

In the report titled, The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to Covid-19, pharmaceutical distributors, manufacturers and other stakeholders in the biopharmaceutical supply chain leveraged their relationships and prior emergency response experience to get medicines safely delivered to patients.

Distributors closely collaborated with manufacturers and hospitals, pharmacies, providers and other partners to anticipate changes in demand, respond to evolving patient needs and mitigate disruptions.

Findings showed:

  • The supply chain was able to balance increased demand through avoidance of single sourcing, supply risk monitoring, communication and data transparency, and proactive inventory management.
  • Distributors promptly set up individual allocation programs to manage inventory of the most in-demand products in an equitable way, which helped contain the shortages initially observed of critical care drugs used to treat Covid-19 patients in ICUs.
  • While drug shortages as measured by the Food and Drug Administration (FDA) increased during the first 90 days, there were few significant disruptions (actual and purported) beyond Covid-19 therapeutics. At least 83 percent of drugs that were reported in shortage to the FDA had a second-line or alternative treatment available.
  • The pharmaceutical supply chain was able to adapt to accommodate changes to the channels through which patients acquired their prescriptions.
  • The biopharmaceutical industry invested substantially in developing capabilities to curb the pandemic’s short- and long-term challenges, including speeding to market coronavirus testing, therapeutics and vaccine candidates, while also supporting communities through in-kind donations.
  • By leveraging their emergency response capabilities, supply chain stakeholders were able to promptly put in place business continuity plans that preserved the health and safety of frontline employees with minimal disruption to their operations.

Additionally, Deloitte’s social sentiment assessment, which monitored and analyzed consumers’ online comments about perceived supply disruptions shows that consumer sentiment for the biopharmaceutical industry improved during the first 90 days of the pandemic, indicating that consumers had a positive perception of the industry’s performance in managing the early challenges of Covid-19.

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors—the link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to Covid-19 received support from several sponsors, including Cardinal Health, CuraScript SD, Novartis Pharmaceuticals, Endo International’s PAR Pharmaceutical, KeySource, Ascend Laboratories, IQVIA and Upsher-Smith Laboratories.

The report is available as a complimentary download through the HDA website.

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Carrier Pods in combo with Sensitech provide new mobile cold storage option

New Carrier Pods monitored by Sensitech combine refrigeration technology and cargo monitoring capabilities to help address the challenges of Covid-19 vaccine distribution. Carrier and Sensitech both are part of Carrier Global Corp., a worldwide provider of building and cold chain options.

The monitored pods are available in configurations that comply with Good Distribution Practice guidelines for pharmaceutical products and address stringent regulatory temperature verification requirements for vaccines.

The Sensitech technology can monitor a wide range of temperatures, including dry ice conditions. The combination of container refrigeration and Sensitech’s advanced monitoring offers deep-freeze cooling, real-time telematics, data analytics and product visibility, according to the companies.

Carrier’s recently announced Lynx digital platform is expected to provide added connectivity by the end of the year. Additionally, the mobility of the Carrier Pods provides pharmaceutical companies, distribution centers, retailers and vaccine administrators with flexibility to move vaccine storage to other locations.

“Maintaining the temperature integrity of vaccines is critical,” said Kartik Kumar, vice president and general manager, Global Container Refrigeration, Carrier. “For greater visibility, customers can remotely monitor the conditions of the container and cargo around the clock.”

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Trebor Rx to begin production of TPE respirator masks in Canada

Trebor Rx, a new venture in Canada, is launching PRO+ Dual Respirator masks, a patent-pending mask made of thermoplastic elastomer (TPE) that can provide more than 300 hours of usage and replace hundreds of disposable masks, according to the company.

The PRO+ Dual Respirator masks (Image credit: CNW Group/Trebor Rx Corp.)

The respirator body is 95 percent recyclable, washable and sterilizable. It is designed to be used across various sectors, including healthcare, dental, mining, construction and military.

This breather technology uses disposable N95 filters, and the company claims it can filter both inhaled and exhaled air, providing protection against the spread of contaminated particles for both the user and the surrounding environment.

The PRO+ Dual Respirator claims a 98 percent effectiveness protecting against Covid-19, other viruses and bacteria, and was tested and certified under EU-GMP, the EN1827, EN149, EN142 respiratory protection standards, and BFE ASTM F2101-19 protocols to evaluate bacterial filtration efficiency.

Production is slated to begin in Collingwood, Ontario with expansion to a larger facility planned for a late 2020 opening. The company forecasts Canadian domestic production capacity of more than 500,000 masks per week.

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New alliance formed to serve biopharmaceutical and life sciences

Rapid Reshore & Development (RR&D), an alliance of three specialized firms working together to provide professional services for the life sciences and biopharmaceutical industries, has formed to address logistical challenges facing companies developing drugs, vaccines and medical devices.

The three firms—Facility Logix, EwingCole and Biggins Lacy Shapiro & Co.—intend to maximize efficiency, minimize risk and facilitate speed-to-market. The alliance represents a shift from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects.

“Our rapidly changing world created a multitude of challenges and opportunities across all industries,” said Jared Loos, PE, AIA, EwingCole’s CEO. “However, few face logistical obstacles like the life sciences and manufacturing sectors, including biopharmaceuticals, medical devices, medical equipment and their respective supply chains. Our goal was to create an alliance that can collaboratively and succinctly support their needs from start to finish.”

Life sciences and biopharmaceutical companies are pivoting to increase efficiency and capacity in record time, which requires quicker decision-making, identifying talent, retooling facilities, increasing capacity and shoring up resources.

According to its launch announcement, RR&D is approaching the speed-to-market process by aligning and accelerating all steps, including: Up-front planning and programming; scenario development and analysis; due diligence of talent market; new facility consideration and comparative costs; early conceptual designs; competitive real estate procurement, and full design/engineering and project management.

In related news, RR&D was selected this week by BrainStorm Cell Therapeutics Inc., a developer of autologous adult stem cell therapeutics, to expedite site selection and design services for a new manufacturing facility for NurOwn, a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis and multiple sclerosis. RR&D will provide project management services throughout the project’s lifecycle.

BrainStorm, which recently signed an agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs, intends to use the proposed 50,000-square-foot facility primarily for cell therapy production.

The facility is expected to contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

Facility Logix, which specializes in the biotech industry, delivers new building solutions, enabling biotech companies to produce or house healthcare products. The company provides owners’ representation, facilities planning, move and transition, as well as project and operational management implementation.

EwingCole, in practice for nearly 60 years, is a fully integrated architecture, engineering, interior design and planning firm with more than 400 professionals located in several US cities.

Biggins Lacy Shapiro & Co. features a multi-disciplinary team—attorneys, project finance and tax professionals, planners and engineers—for complex projects and portfolios through site selection, incentives and customized energy needs. Over the years, the firm has advised numerous pharmaceutical, gene therapy, biotechnology and consumer health companies.

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Envirotainer adds four new RAP e2 stations in the US

Envirotainer, a global provider of temperature-controlled air freight equipment and technology for pharmaceuticals, is increasing its RAP e2 network capacity in the US by 57 percent.

The four new RAP e2 stations in New York, Miami, Philadelphia and Seattle will increase the capacity to securely ship both Covid-19 vaccines as well as all other medicines that require high-quality temperature-controlled packaging solutions.

Secure cold chain services for the pharmaceutical supply chain.
(Image credit: Envirotainer)

The move will help bring the active temperature-controlled unit closer to the manufacturing hubs of the company’s pharmaceutical customers, according to Eddy Cojulun, chief sales officer at Envirotainer.

“In light of upcoming Covid-19 vaccine shipments and the expected demand surge that it will bring, having the right solution readily available will significantly reduce the time-to-market for these life-saving vaccines once they are ready for global distribution,” Cojulun said.

Envirotainer’s strategy is to expand capabilities across the globe to meet the upcoming demand. In addition, the company says it will be positioned to handle other forthcoming temperature-sensitive shipments that require a 2-8°C or -20°C controlled environment.

The company has been expanding its commercial offerings in the US over the past decade investing in both service delivery and operational capabilities, with a focus on an agile network model. The addition of JFK, MIA, PHL and SEA will bring the total number of RAP e2 stations for the mainland US to 11 along with one in Puerto Rico.

The other RAP e2 stations are located in northern New Jersey, Atlanta, Chicago, Indianapolis, Dallas/Fort Worth, Los Angeles, San Francisco and San Juan.

Envirotainer provides a total of 41 RAP e2 stations across the world, servicing cold-chain requirements. The four new US stations are commercially ready to receive bookings starting this week, according to the company.

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CSafe expands further into Latin America

CSafe Global, provider of temperature-controlled containers for the transport of pharmaceuticals, has opened a new hub operation in Mexico City, the second largest pharmaceutical market in Latin America after Brazil.

Mexico City (Image courtesy of CSafe Global)

“We are thrilled to add our second facility in Latin America in 2020,” said Tom Weir, chief operating officer at CSafe. “The market growth has been tremendous across the region and we expect to see more development as the pharma supply chain begins to diversify their operations to better manage demand in a pandemic or any other situation that comes in the future.”

The company has contracted with AAACESA to make air cargo units available at its Mexico City International Airport facility. Through the arrangement, CSafe will gain access to 7,000 square-feet of space to store its RKN and RAP containers.

Dayton, OH-based CSafe Global with a presence in 150 countries provides end-to-end thermal shipping for pharmaceutical and life science industries worldwide.

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Reflect Scientific awarded patent for low temperature bulk shipping system

Reflect Scientific, Inc. has been awarded a patent for a cryogenic modular shipping unit that can uniformly maintain its payload at temperatures as low as -90°C, making it suited for cold chain management of biologics including Covid-19 vaccines.

The cryogenic system provides a capability of short or long duration bulk shipping and may also be used for long-term storage.

Low-temperature shipping system for high-value vaccines and biologicals. (Image credit: Reflect Scientific, Inc.)

The commercially available Cryometrix S-90 shipping system eliminates managing loads of dry ice, waiting hours for the temperature to saturate the shipping container, and having little to no control over product temperature during shipping.

It bundles Reflect Scientific’s upright liquid nitrogen freezer technology with an onboard liquid nitrogen tank and power supply. The user can ship up to 33.5 cubic feet of product (or 70,000 vials) at a controlled temperature between +20°C down to -90°C with a uniformity of ± 3°C.

The S-90 features temperature and data logging that can be accessed through the touch screen or downloaded to a computer. Security issues are mitigated with three security levels and up to 30 users. It can control who opens the freezer, changes the temperature set-point and changes the settings.

Each Cryometrix shipping system is customizable to meet individual shipping needs, including for vaccines and biologics, whether used for cross country shipping at -90°C or for short trips, according to the company.

Reflect Scientific, based in Orem, UT, develops and markets proprietary technologies in cryogenic cooling for the biotechnology, pharmaceutical, medical and transportation markets.

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LaunchWorks makes FDA list of approved viral transport media vendors

LaunchWorks, a contract development and manufacturing organization (CDMO) serving the life sciences market, has been approved to manufacture and distribute viral transport media (VTM), in accordance with Section IV.B of the FDA’s Covid-19 transport media policy.

(Image credit: LaunchWorks)

The VTM, a new addition to the company’s products and services, is available in the form of bulk tubes, large volume containers and a specimen kit, which will include a tube of sterile LaunchWorks VTM, a biohazard bag and an absorbent bag. Additional options include nylon-flocked NP swab, barcode or QP-coded labels, patient card and a UN 3373 return box.

As an FDA-registered ISO 13485 certified company, LaunchWorks is a division of Integreon Global, which has supported the CDMO’s expansion in molecular diagnostics with the additions of new service offerings, including embarking on an automation program. Recently, a significant portion of the company’s efforts have involved the response to the Covid-19 crisis, and the development of VTM.

Integreon Global includes four companies: LaunchWorks, Cryopak, DDL and NexKemia. Each company offers unique critical supply chain components, including cold chain temperature monitoring options, packaging, product and materials testing, contract manufacturing and EPS resin manufacturing.

The LaunchWorks service suite ranges from package design to formulation, filling and fulfillment.

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SkyBitz and Coretex enter strategic alliance to integrate reefer and trailer tracking

IoT telematics company SkyBitz and fleet logistics technology provider Coretex are partnering to provide pharmaceutical, food and other customers with improved safety and quality assurance through visibility into the status of loads during transportation.

The move combines Coretex’s sensor-based reefer technology and cloud-based software platform with SkyBitz’s trailer tracking technology for both powered and non-powered asset tracking.

Users can access and manage both reefer device data and trailer tracking data via one connected platform, enabling greater insight, a more transparent view of their entire cold chain operation, and better decision making, according to the companies.

It also allows users to keep assets on the road for longer periods, monitoring them with advanced temperature tracking capabilities.

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UNICEF to stockpile more than a half billion syringes by year end

In anticipation of forthcoming Covid-19 vaccine approvals, the United Nations Children’s Fund (UNICEF) announced plans to stockpile 520 million syringes in its warehouses, part of a larger plan to have a billion syringes ready for use through 2021 in order to guarantee initial supply and help ensure that syringes arrive before vaccines are distributed.

To make sure that vaccines are transported and stored at the right temperature, UNICEF, along with the World Health Organization (WHO), is also mapping out existing cold chain equipment and storage capacity in both the private and public sectors, and preparing necessary guidance for countries to receive vaccines.

“We are doing everything we can to deliver these essential supplies efficiently, effectively and at the right temperature, as we already do so well all over the world,” said Henrietta Fore, UNICEF executive director.

Prior to the Covid-19 pandemic and with support from the global vaccine alliance Gavi and in partnership with WHO, UNICEF has been upgrading the existing cold chain equipment across health facilities in countries to ensure that vaccines remain safe and effective throughout their journey.

Since 2017, more than 40,000 cold-chain fridges, including solar fridges, have been installed across health facilities, mostly in Africa, and solar technologies are being promoted in many countries to help maintain supply chains, according to the agency.

In South Sudan, the least electrified country in the world, where temperatures frequently exceed 40°C, more than 700 health facilities have been equipped by UNICEF with solar-powered fridges—about 50 percent of all facilities in that nation.

UNICEF says the Covid-19 vaccination efforts will be on top of the 620 million syringes the agency intends to purchase for vaccination programs against other diseases such as measles and typhoid.

“By the end of the year, we will already have over half a billion syringes pre-positioned where they can be deployed quickly and cost effectively,” said Fore. “That’s enough syringes to wrap around the world one and a half times.”

UNICEF is also buying five million safety boxes, each capable of carrying 100 syringes, so that used syringes and needles can be disposed of in a safe manner by personnel at health facilities, reducing the risk of needle stick injuries and blood borne diseases.

The agency, originally known as the United Nations International Children’s Emergency Fund, was created by the UN General Assembly on December 11, 1946, to provide emergency food and healthcare to children and mothers in countries that had been devastated by World War II. Its mandate was later extended to address such long-term needs in all developing countries, dropping the words ‘international’ and ‘emergency’ from the name in 1953, but retaining the original UNICEF acronym.

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UK importers/exporters warned to take immediate action as Brexit nears

Many businesses trading abroad ‘are in the dark’ about what they should be doing to prepare financially for the Brexit January 1, 2021 deadline, according to feedback received by Hamilton Court FX, a UK-based consulting firm that provides foreign exchange (FX) transactional advice and delivery.

Importers and exporters, including those in pharmaceuticals, shipping, logistics, insurance and other businesses are worried about the government’s failure to provide clear detail sooner to guide them through UK and European Union bureaucracy.

With eight out of 10 businesses still ‘sitting-on-the-fence’ and waiting for detailed government advice on the changes to the way they import/export goods and pay for them, the consulting group warns that it is imperative that they act now with proactive methods of hedging their currency needs so market fluctuations don’t eat into their profits.

“We have been receiving feedback from our clients for a year or more on their frustration with government over Brexit advice,” Mark Palmer, chief operating officer of Hamilton Court FX, said. “There is little available and no one to speak to. There is no one-size-fits-all answer here, which is why businesses need to speak to someone. All their issues are different and there are less than 80 days to go.”

Last week the British government sent an email to businesses with links to its website that purport to offer advice on dealing with the changes brought on by operating outside of the UK post-Brexit, the consultancy noted.

“The portal offers us no tangible advice that hasn’t already been covered externally and by comparison misses a lot of key elements of consideration,” Palmer said, adding that the firm is countering ‘Brexit fatigue’ by offering the following advice to help companies implement active strategies to ensure that they’ll know where they stand with foreign exchange, including:

Check

  • What implications a large delay in receipt or delivery of inventory will have on cashflows and any underlying foreign exchange contracts allocated to them.
  • Whether a 10 percent move up or down in the value of the British pound will leave them having to pay extra collateral against hedging contracts.
  • The types of hedges being used: Are there more suitable methods?
  • Whether businesses in their supply chain are protecting themselves against financial exchange risk and if they would suffer as a result of any adverse effects they experience.
  • The small print.

Change

  • A non-responsive banking relationship.
  • Terms with suppliers – are they able to get some payment flexibility if required, rather than breach any strict terms that don’t make a Brexit

Go

  • Speak to people in the industry. What are they doing?
  • Act on the information they’ve got and avoid procrastination.
  • Get on top of the variables that they are in control of to reduce other distractions.

The firm also offered some alternative FX strategies instead of waiting:

  • Start small, hedge 50 percent of what they would regularly. This lowers the potential risk, while only giving up some of the potential upside.
  • Change the product mix. Something that is happening at scale already.

Hamilton Court FX added suggestions that businesses should consider with their FX product mix: A lower potential obligation; structures that allow for upside flexibility or that can deliver a level of outperformance vs. vanilla products if their risk tolerance allows for it; trades with low or zero chance of margin call, and working with an expert to tailor a trade that aligns with the company’s market view, while still delivering the level of protection required.

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Digi unit meets expected CDC monitoring guidelines for Covid-19 vaccines

The SmartSense division of Digi International announced this week that its monitoring services meet expected guidelines from the U.S. Centers for Disease Control and Prevention (CDC) for handling Covid-19 vaccines and that its solutions will support the entire vaccine cold chain from manufacturers to end-point providers.

At present, SmartSense technologies collect more than 10 million sensor readings per day in 28,000 retail pharmacy locations and their supporting distribution centers.

The CDC is expected to mandate continuous temperature monitoring for pharmacies to receive and distribute forthcoming Covid-19 vaccines. To meet the requirement, SmartSense provides automated wireless-monitoring and task-management tools that ensure the product remains at the proper temperature and that workers handle the inventory correctly.

With many vaccine candidates requiring frozen transportation and storage, the division reports that it can support such conditions without upgrades or hardware changes, and that its sensors can monitor the ultra-cold conditions required for vaccine delivery.

“Our pharmacy customers have already entrusted us to protect more than $2 billion in refrigerated inventory,” said Kevin C. Riley, president of SmartSense. “In addition, we’re also working with hospitals, clinics and transportation companies that use our technology for similar applications.

Digi International is a global provider of business and mission-critical Internet of Things (IoT) connectivity products and resources. Boston-based SmartSense, Digi’s IOT Solutions division, serves more than 2,000 organizations in 75 countries, including at Walmart, CVS Health, SpaceX, Apple, Coca Cola, McDonald’s and the US Department of State, according to the company website.

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DataLase launches functional masterbatch additive for plastics integration

DataLase, a photonic printing specialist, has developed a masterbatch additive suitable for a range of plastics for pharmaceutical, medical and other industries.

The additive addresses challenges faced by production and manufacturing companies with product coding applications, such as printing expiration dates and lot numbers.

Launched under the company’s VAReLase Pigment Solutions banner, the additive is integrated directly into the masterbatch in pellet form to provide consistent quality, contrast and permanent black coding.

The additive works with standard CO₂ scribing lasers to provide sustainability benefits in production environments by eliminating labels, consumables and waste from the coding and marking process, according to the company, which adds that it also can help streamline supply chains through a reduction in packaging.

Since the additive already is integrated into the extruded plastic, it provides SKU traceability through permanent tamper-proof anti-counterfeit coding, and can be printed anywhere on the packaging, the company reports.

DataLase is based in Cheshire, UK. Distributor partners include SunChemical, Hubergroup and UVitec.

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Drone deliveries of cold chain medicines begin in rural North Carolina

Volansi, Inc., an on-demand aerial delivery service for time-critical shipments, has begun delivering cold chain medicines from Merck’s Wilson, N.C. manufacturing site to Vidant Healthplex-Wilson, a medical center operated by Vidant Health and serving rural portions of the state.

Initial flights in the project resulted in the first drone delivery of temperature-controlled medicines within the U.S., according to Volansi. The move represents the first part of a three-phase project to learn about drone technology’s role and ability to improve access to healthcare.

Pilot program may help establish new supply chain option. (Image courtesy of Volansi, Inc.)

“We’ve seen the world’s supply chain strained like never before from the impact of Coronavirus,” said Hannan Parvizian, CEO and co-founder of Volansi. “There’s now an accelerated need for rapid advancements in supply chain technology, especially in healthcare. Drone delivery is one solution to getting critical supplies where they are needed, at the moment they are needed most.”

The project utilizes Volansi’s VOLY C10, an all-electric drone capable of carrying 10-pounds of cargo to locations up to 50 miles away. The VOLY C10’s vertical take-off and landing (VTOL) system allows it to deliver fragile cargo with a ‘soft touch’ automated release once the drone has landed at the delivery location.

The VTOL system requires minimal infrastructure to operate and also is capable of delivering such items as temperature trackers and shipping confirmation on returning flights.

“As a healthcare leader, Merck is very supportive of collaborations using new technologies to explore how one day we could help better serve the healthcare community,” said Craig Kennedy, senior VP, global supply chain management, at Merck, which is known as MSD outside the U.S. and Canada. “Our existing distribution system is strong, and this pilot helps us explore new innovative delivery options that would complement our existing supply chain capabilities.”

Volansi is working with the Federal Aviation Administration’s (FAA) Unmanned Aircraft System Integration Pilot Program and the North Carolina Department of Transportation to ensure that its deliveries are made safely and in accordance with state and federal guidelines.

For phases two and three of the project, Volansi said it plans to seek additional approval from the FAA to provide deliveries in other locations, enabling a flexible, on-demand and responsive supply of critical medicines.

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Etihad Cargo to utilize latest CSafe high-performing containers for flights

Etihad Cargo has approved the use of CSafe Global’s high-performing container, the CSafe RAP, across its global fleet of wide-body and freighter aircraft. CSafe Global provides end-to-end thermal shipping for the pharmaceutical and life science industries with a presence in more than 150 countries.

(Images courtesy of Etihad Cargo and CSafe Global)

The CSafe RAP uses new heating and compressor-driven cooling technologies, along with advanced VIP insulation, to maintain constant payload temperatures even at extreme ambient temperatures spanning from -30°C to +54°C – reportedly the broadest operating range in the industry.

Its large payload compartment of 6.68 cubic meters (235.902 cubic feet) accommodates up to four standard U.S. pallets or five standard Euro pallets. With an extended battery run time of more than 120 hours, the CSafe RAP provides temperature integrity and product viability through to destination, including on extended journeys.

Etihad Cargo recently reinforced its pharmaceutical logistics capabilities with the launch of PharmaLife, a specialized pharma and healthcare service that comprises both active and passive containers and associated ground services. It was the first carrier in the Middle East to receive the IATA’s Center of Excellence for Independent Validators (CEIV) certification in pharmaceutical logistics.

“We are confident as market demands become stronger for vaccines and clinical trials that we are ready to offer quality along with enough capacity to our customers,” said Fabrice Panza, global cold chain manager at Etihad Cargo.

Etihad Cargo, the cargo and logistics arm of the Etihad Aviation Group, has been a long-time partner with CSafe Global and provides a number of closed cold-chain solutions, including the CSafe RAP and CSafe RKN. Sale and leasing options for the containers are available through Etihad Cargo.

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BioLife division gets $2.7m cold chain and storage contract for Covid-19 vaccines

BioLife Solutions, Inc.’s recently acquired SciSafe division has been awarded a two-year contract estimated at $2.7 million from an unnamed ‘large pharmaceutical company’ for cold chain management and storage of Covid-19 vaccines.

SciSafe, a provider of biological materials storage founded in 2010, maintains four cGMP-compliant facilities located in New Jersey, Massachusetts and Utah, with an expansion plan focused on the cell and gene therapy clusters located around the world.

While BioLife leadership did not name the pharmaceutical company in the $2.7 million agreement, the company last month reported that SciSafe customers include several Top Five global pharmaceutical companies.

In an interview published last week with Seattle’s Pugent Sound Business Journal, BioLife CEO Mike Rice said the company’s storage technology would not be used for transport of the Covid-19 vaccine, but declined to add further details about the newly signed contract.

BioLife is a developer and supplier of bioproduction tools and services for cell and gene therapies. SciSafe, acquired in September, is expected to contribute approximately $9 million in incremental revenue in 2021, according to BioLife.

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Covectra introduces suite of services for comprehensive serialization and traceability

Covectra has launched a suite of serialization and track & trace engineering, integration and consulting options to complement its products and services, allowing businesses to address supply chain challenges, optimize technology products and implement new processes quickly and cost effectively.

Technical help in serialization is available across a broad set of industries including pharmaceutical and life sciences for implementation of smart strategies that provide visibility and full traceability along the digital supply chain. It also assists in the customizing, implementation and integration of technology needed to optimize resources and ensure the supply chain’s integrity.

“Our customers are struggling as the growing threat of counterfeit products from drugs, cosmetics to tobacco floods their markets, and puts their brands at risk,” said Steve Wood, Covectra’s CEO. “Also, their resources are being drained by constantly changing regulations and they need to focus on their business requirements.”

Support offered for serialization services includes:

  • Requirements, compliance and implementation plans
  • Line selection criteria and installation planning
  • Equipment analysis and selection
  • Serialization-ERP integration
  • Vendor assessment and selection
  • Technology assessment

Covectra provides serialization, track & trace, and authentication technologies to secure and manage products across the entire supply chain extending to the unit dose level. The company also can provide a user requirements study for serialization and other engineering functions, printing and vision system planning and Level 4 integration.

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Air transport groups find ‘a concerning lack of readiness’ for Covid-19 vaccine logistics

The International Air Cargo Association (TIACA) and Pharma.Aero, a cross-industry consortium focused on reliable end-to-end air transportation for pharmaceutical shippers, this week sounded an alarm over the current state of air cargo readiness for upcoming Covid-19 vaccine transportation.

The two organizations recently surveyed airlines, freight forwarders, ground handlers, airport operators and solution providers to gauge their preparedness to handle the global logistics effort to distribute the upcoming vaccines.

While the vast majority of respondents have begun preparations to handle, store, transport and deliver the future Covid-19 vaccines, only 28 percent of them feel well prepared to do so at this time.

On that basis, TIACA and Pharma.Aero this week issued a call for “urgent industry collaboration” to address what they termed “a concerning lack” of readiness.

“We as an industry are as strong as our weakest link,” said Emir Pineda, member of TIACA’s board and co-lead of the joint Sunrays project initiated in August to help the air cargo industry get ready for the transportation of the Covid-19 vaccines.

“To move the needle on industry readiness, we need to ensure everyone is engaged and informed,” Pineda said. “Only with a strong and transparent dialogue between pharmaceutical and air cargo sectors, governments, non-governmental organizations and healthcare institutions can we overcome these challenges.”

Areas of immediate priority, according to the two air transport groups, require a focus on industry collaboration between the pharma and air cargo sectors; improving visibility and transparency; building adequate capabilities; getting support from regulators to speed up the process and remove cumbersome procedures, and receiving help from international organizations and donors to ensure that no country is left behind.

Such coordinated action would provide the maximum air cargo preparedness required to meet shippers’ needs and expectations for speed, security, reliability and transparency.

To strengthen industry collaboration, the survey sponsors called for vaccine manufacturers to involve all of their air cargo logistics providers, including airports and ground handlers, as early as possible.

TIACA and Pharma.Aero also called on air cargo stakeholders to map existing capabilities at each location and make the information available; secure dry ice, active containers, trained staff and cold chain space availability early in the process, and to start making any necessary infrastructure investment decisions.

To improve visibility, they suggested that the use of tracking and monitoring devices should be encouraged and the approval process for their safe use in flight should begin ASAP, along with the accelerated rollout of digital solutions and data sharing platforms.

As for removing barriers, TIACA and Pharma.Aero suggest that governments, customs authorities and border agencies should be ready to facilitate and expedite all Covid-19-related goods, and that international organizations, NGOs and donors should support cold chain capacity building efforts in the least-developed countries to ensure that no one is left behind in the upcoming global immunization campaign.

“We are still at early stages of industry preparation for the transportation of Covid-19 vaccines and there are still a lot of unknowns,” said Nathan De Valck, chairman of Pharma.Aero’s board and member of the Sunrays project. “Getting the equation right requires us to work together now.”

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Momentive Technologies and Stevanato Group collaborate on vials packaging

Momentive Technologies and Stevanato Group agreed to supply Momentive’s Pur Q fused quartz vials in Stevanato’s EZ-fill packaging format.

The Pur Q vials are ultra-high-purity fused quartz vials available for pharmaceutical packaging. The EZ-fill secondary packaging provides a fully integrated, ready-to-use option for aseptic fill-finish operations.

Pur Q fused quartz vials. (Image courtesy of Momentive Technologies)

Combined, the move is expected to help biopharmaceutical companies improve the reliability and speed of drug development and production of medications via highly stable primary packaging and an efficient secondary packaging method.

Made from 99.995 percent pure silicon dioxide (SiO2), the Pur Q fused quartz vials have an inert, nonreactive surface that virtually eliminates risk of interaction with packaged drug formulations.

“Due to the vials’ highly inert properties, biopharmaceutical companies will be able to confidently take the container out of the equation when assessing the viability of formulations, helping to accelerate the development of increasingly complex and sensitive biologic drug formulations,” said Robert Koch, global commercial director at Momentive Technologies.

The EZ-fill secondary packaging is designed to mitigate the risk of breakage, cosmetic issues and particulate generation during fill-finish operations. The packaging stores vials safely in a tray, or nest and tub configuration for efficient filling, while minimizing glass-to-glass contact.

EZ-fill packaging stores vials in tray or nest and tub configuration. (Image courtesy of Stevanato Group)

Momentive Technologies, headquartered in Strongsville, Ohio, employs more than 700 workers and maintains seven manufacturing locations in the U.S., Germany, Japan and China. Formerly a division of Momentive Performance Materials, the business became a separate stand-alone entity in January.

Privately owned Stevanato Group, based in Piombino Dese, Italy, is a designer and producer of glass primary packaging for the pharmaceutical industry. In September, the company launched a Technology Excellence Center in Boston to support biopharma companies from early phase development through to commercialization, helping them overcome container-closure system hurdles.

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Authentix acquires Bibliotheca anticounterfeiting unit

Authentix, Inc., an authentication and information service based in Addison, TX, has acquired the Traceless Authentication Group from Bibliotheca, Inc. a library systems company serving libraries worldwide.

Rochester, NY–based Traceless delivers anticounterfeiting and diversion control options to customers in the global pharmaceuticals, spirits, and apparel industries. The acquisition includes the company’s complete portfolio of patented covert marking solutions as well as its own enterprise cloud-based digital track and trace software technology.

Product lines acquired include Traceless Ultra, Traceless Pro and Traceless Anti-Diversion covert marking systems that can be integrated into existing product production.

“Traceless brings an extensive capability in the worldwide digital tracking of products and consumer-level product marketing, both of which integrate well with our growth strategy,” said Kevin McKenna, CEO of Authentix.

In addition to the U.S., Authentix has offices in the United Kingdom, Saudi Arabia and Africa. MHT Partners, L.P. acted as financial advisor to Authentix in the transaction.

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Balaxi Ventures renamed to better reflect its core focus on pharma

India’s Ministry of Corporate Affairs has granted formal approval to Balaxi Ventures Ltd to change the company’s name to Balaxi Pharmaceuticals Ltd. The move received shareholder okay last month at the company’s annual general meeting.

Hyderabad, India-based Balaxi supplies “frontier” markets in Angola, Guatemala and the Dominican Republic with branded, generic and over-the-counter medicines that address multiple therapeutic segments. The products are procured from World Health Organization GMP-certified contract manufacturers based in India, China and Portugal.

“Considering our focus on pharma business, it is only apt that the company’s name reflects our brand proposition,” Ashish Maheshwari, managing director, commented regarding the name change.

The company maintains an on-ground presence with 38 warehouses and a distribution network featuring a fleet of company-owned vehicles. It reports that it currently is building a branded fast-moving-consumer-goods (FMCG) business to complement its pharmaceutical operations while taking advantage of its established on-ground infrastructure and channel relationships.

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Meeting the challenges of rapid Covid-19 vaccine cold chain deployment

For months, pharmaceutical organizations and researchers worldwide have been focused on developing a vaccine for Covid-19. “Operation Warp Speed” (OWS), a collaboration among several U.S. governmental departments and 18 biopharmaceutical companies, was created to accelerate the development of a Covid-19 vaccine.

Upon vaccine approval, OWS will aim to deliver 300 million doses by January 2021. This is an unprecedented and complicated challenge, given the speed of deployment, global scale of distribution, and because some vaccine candidates must be stored at ultra-low temperatures (ULT), which are beyond the normal cold storage range for vaccines (-40°C to -4°C).

Although OWS accelerated vaccine development/testing, meeting the cold chain storage requirements of a vaccine could prove the project’s most daunting challenge.

Today, few vaccine manufacturers, third-party logistics (3PL) providers, healthcare systems or pharmacies are set up to continuously store and transport vaccines in temperatures as low as -80°C. Therefore, to meet this monumental task, these organizations must rapidly ramp up ULT cold chain capacity—from end to end—to safely store and deliver vaccines to hundreds of millions of people.

There is a lot at stake. The World Health Organization estimates that more than 50% of vaccines lose their efficacy globally every year due to the lack of proper temperature control, logistics or shipment-related issues. Given the urgent global need for a Covid-19 vaccine, this is not an option. By proactively addressing key challenges, manufacturers, regional 3PLs and local points of patient care can rapidly deploy the ULT freezers needed to maintain vaccine efficacy while mitigating potentially negative financial and infrastructural impacts to their organizations.

Challenge: Be prepared for the range of temperatures at which multiple Covid-19 vaccine candidates may have to be stored

There are currently more than 30 vaccines in the testing pipeline worldwide, so it’s not yet possible to tell at which temperatures an approved vaccine will need to be stored. It already appears that certain candidates will require -80°C storage, while others may only require -50°C to -40°C and warmer storage. Not being able to meet the storage requirements of any one of the viable vaccine candidates could put all cold chain stakeholders at a disadvantage. The smart play is to cover all the bases now, so that they will be ready the moment vaccine approval arrives.

Solution: Choose ULT freezers with the widest temperature range to optimize cold storage setpoints for most/all vaccine candidates

Look for ULTs that can maintain the broadest range of temperature setpoints (from -86°C to -20°C), not a limited range starting below -50°C. By opting for a ULT freezer that supports a wider range of temperatures, facilities can accommodate the storage efficacy requirements of more vaccine candidates, regardless of which are ultimately approved.

Challenge: Overcome facility infrastructure obstacles when quickly ramping up ULT freezer capacity

Few distribution center facilities are designed to house high-volume biobanking operations. As 3PLs and pharma distributors find themselves rapidly adding ULT freezer capacity, they can expect to encounter infrastructure challenges, including heat generation, limited floor space, power demands and high energy costs.

Equipment options

Generally speaking, there are three available choices for ultra low-temperature storage: continuous replenishment of dry ice (CO2) or liquid-nitrogen (LN2) units; conventional compressor-powered freezers, and the free piston Stirling engine units offered by Stirling Ultracold.

Deploying CO2 or LN2 units in regions or locations where those commodities are readily available has been the solution for years; typically, they are not shipped long distances. However, the risks associated with handling, the negative impact on the environment and lack of control over individual vial temperature has pushed the industry to find better solutions. Freezers came into play as technology advanced, but freezer operation depends on continuous power availability and reliable monitoring and plenty of space to work with a number of recent events where freezers failed (and precious biobanked materials were lost forever) because of monitoring or maintenance upsets.

Conventional compressor-driven units have the advantage of being familiar to HVAC and other facility engineers—the technology is well-understood. Once ambient temperatures exceed 26.7°C, however, compressor-based systems must work more, compromising efficiency, reliability and even shortening freezer lifespans. As compressors work harder, they produce even more heat. And as temperatures in these facilities rise, the HVAC systems will also have to work harder, leading to increased strain on the HVAC systems, higher energy costs and a vicious cycle of additional compressor work required to keep up. Once ambient temperatures exceed 32.2°C, system reliability can be compromised when using compressor-based units, placing vaccines at risk.

The HVAC factors are especially relevant to pharmaceutical distribution centers and healthcare systems, which are generally not equipped to handle ULT products (unlike biobanks). Since distribution centers are typically not equipped for such significant HVAC loads and the need for additional freezer space, this new challenge could involve unforeseen building modifications, which potentially can threaten the planned ULT deployment budgets and schedules managed by 3PL organizations.

An alternative choice is Stirling-cycle freezers. This technology (now over two centuries old, but substantially advanced by Stirling Ultracold), employs a frictionless moving piston that uses a linear displacement mechanism and a working fluid (helium), within a hermetically sealed container, to achieve ultra-low temperatures within the freezer closet. As there is no rotating compressor mechanism, the unit is relatively maintenance-free with no need for oil lubrication. The engine technology boasts precise performance across a wide temperature range (-86°C to -20°C, adjustable in 1°C increments) in higher operating ambient temperatures, and has been field-proven to ensure long-term sample safety in more than 15,000 freezer installations and over 250 million run-time hours.

Economics and efficiency

In terms of total cost of ownership, Stirling Ultracold ULT freezers are generally priced at a 20-30% premium over compressor-driven models. However, this initial premium is quickly offset with operating cost savings of 40% or more over the lifetime of standard compressor-based ULT freezers.  They have the capacity for more sample storage in the smallest footprint and connect directly to establish lab management programs for simpler monitoring. In 2017, Stirling Ultracold earned a 0.286 kWh/day/ft3 certification from Energy Star®, the lowest energy use and heat output per sample capacity of any certified ULT freezer and making the freezer a highly sustainable device.

Stirling Ultracold units come in a variety of models to best-fit the customer need. They are available as portable models (storage volume of 25 liter, 0.9 cu. ft.) for clinical use, compact, under-counter laboratory units (storage volume of 105 liter [3.7 cu. ft.) to larger upright biobanking units (storage volume of 780 liter [27.5 cu. ft.) The units can run on 120 or 240VAC to support global use, and remove the need for special personal protective equipment (PPE) required with CO2 or LN2.

One of the major reasons Stirling Ultracold has been selected as an early participant in this vaccine distribution is because of the uncertainty surrounding which vaccine candidates will be first available and what cold storage temperatures will ultimately be needed. Vaccine distributors are trying to “cover all their bases” and be ready the moment vaccine approvals arrive. Stirling Ultracold’s technology is being globally recognized as the only solution to offer a wide range of temperature setpoints, thus optimizing the storage temperature for the Covid-19 vaccine candidates currently within the approval pipeline.

 

About the author

Dusty Tenney is the CEO of Stirling Ultracold. He brings deep industry experience having held senior executive positions as SVP and president, respectively, within PerkinElmer and Brooks Automation. Prior work includes positions at GE Aerospace, AlliedSignal and Honeywell. Tenney holds a BS in Mechanical Engineering from the University of Maryland – College Park and a MS in Mechanical Engineering from the University of Vermont, where he worked for GE Aerospace and graduated from their Edison Engineering Program.

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Mapi Pharma earmarks space for vaccine production facility

Mapi Pharma Ltd., a late clinical stage biopharmaceutical company, plans to dedicate production capacity at its Jerusalem Har-Hotzim manufacturing facility for upcoming Covid-19 vaccines destined for Israel, the European Union and other potential locations.

The company’s GMP facility is audited by the Israeli Ministry of Health, with approvals that are mutually recognized by the EU, thus exempting Israeli manufacturers from the requirement to perform laboratory tests on shipments heading to Europe.

Mapi has invested more than $100 million to expand its Jerusalem fill & finish facility, a unit that originally was established by Johnson & Johnson to supply J&J’s own needs of sterile products. Mapi now is adding a new line for sterile filling and finishing of liquids and powders for injections.

“We are making available our production capacity, as well as our cold chain and storage capacities, for the delivery of vaccines to Israel and EU,” Ehud Marom, chairman and CEO of Mapi, said in a statement. “By making our manufacturing capacity available, we hope to assist in the quick deployment of vaccines once they are approved by the heath authorities.”

Mapi is headquartered in Israel, with R&D operations in Israel and China, an active pharmaceutical ingredient production facility in the Neot-Hovav Eco Industrial Park near Beer Sheva, Israel, and an aseptic manufacturing and fill & finish facility in Jerusalem.

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‘Green’ new reefer trailer being tested for pollution-free shipping of biologics

Reflect Scientific, Inc., a provider of products and services for the biotechnology, pharmaceutical and transportation industries, has been testing an electric-powered heavy-duty truck to potentially replace the diesel-powered tractor trailers that currently are in use for the movement of goods requiring controlled temperatures.

Cryometrix 53-foot reefer trailer (Credit: Reflect Scientific, Inc. via GlobeNewswire)

The Cryometrix CB-40 TRU is a pollution-free refrigeration alternative to diesel-powered systems, according to the company, which added that system weight is comparable to diesel units and can be retrofitted into existing trailers. The CB-40 uses a patented self-contained liquid nitrogen cooling system to achieve consistent temperature control with few moving parts.

The new 53-foot reefer trailer offers a temperature setpoint control that can be adjusted to match payload requirements that potentially could be used for shipping of biologics such as upcoming Covid-19 vaccines.

Demonstration runs conducted from Salt Lake City to Los Angeles and Denver reportedly were successful with the 525-mile Denver run going through varied outside air temperatures and multiple stops for unloading while maintaining internal temperature at -15°F.

Reflect Scientific, based in Orem, Utah, develops and markets proprietary technologies in cryogenic cooling for the biotechnology, pharmaceutical, medical and transportation markets.

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International logistics firm takes steps to build supply chain visibility and resiliency

Chicago-based project44, a supply chain visibility and logistics service, announced a series of new capabilities offering enhanced collaboration, automation and predictive insights to help shippers drive performance, productivity and customer experience.

In the pharmaceutical and biotech sectors the company provides a range of temperature control services, predictive tracking, secure data flow, collaboration, rapid carrier onboarding and accelerated ROI, according to the company.

Transportation and shipping types served by project44 include air, rail, ocean, truckload, less-than-truckload, final-mile and other modes in more than 120 countries.

“With increasing demands for agility, the world’s leading brands are looking for a new level of real-time collaboration, automation and predictive insights,” said Jett McCandless, founder and CEO of project44. “Our new capabilities can help them make faster, more effective decisions and, as a result, build more resilient supply chains.”

The newly launched capabilities include:

  • Improved carrier collaboration: Transportation carriers now have access to a carrier-centric interface that visualizes current and historical shipment data along with benchmarks broken down by lane. Shared real-time access to tracked shipments and analytics enables a more collaborative relationship that improves service levels, reduces costs and empowers more efficient exception management.
  • Increased pre- and post-shipment workflow automation and orchestration: Organizations can automate and orchestrate truckload and less-than-truckload tender as well as dispatch and digital document retrieval processes, including electronic bill of lading and proof of delivery in North America and Europe.
  • Harness multimodal data to unlock predictive insights: Deeper predictive and exception management capabilities are provided to proactively manage multimodal shipments. Real-time condition monitoring with configurable notifications ensures regulatory compliance and significantly improves cold chain visibility on temperature-sensitive shipments for pharmaceutical, food and beverage and consumer packaged goods companies.
  • Gain order and inventory level visibility: Enhanced order and inventory visibility improves operational efficiency, on-time delivery and proactive decision-making by providing a single view of associated SKUs, orders and shipments, while also predicting risk using a predictive health scoring algorithm.

Life sciences companies using project44 services include AbbVie, Bayer, the Alcon unit of Novartis, pharmacy chain Walgreens and medical equipment company ResMed, according to the project44 website.

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MilliporeSigma making headway on new membrane production plant

Progress continues on MilliporeSigma’s new $165-million membrane production plant in Darmstadt, Germany, part of an overall $1.2 billion global headquarters investment that Merck KGaA announced last year.

New membrane production plant. (Image courtesy of MilliporeSigma)

The membranes are critical components in Millipore Express aseptic filters that help ensure the sterility of biological drug products.

“This investment increases our membrane manufacturing capacity and allows for more supply chain diversification,” Chris Ross, interim CEO of MilliporeSigma, said as the company held a topping-out program for the new manufacturing facility this week.

Construction began in March and is expected to be completed in 2022, followed by production process validation and commercialization. The new four-story membrane plant will incorporate immersion membrane casting equipment, quality control laboratories and offices, and add about 55 new jobs, according to the company.

Millipore Express membranes manufactured at the new Darmstadt facility will be processed into filters for pharmaceutical production at MilliporeSigma’s existing device center in Jaffrey, New Hampshire.

The life science business of Germany-based Merck KGaA, which operates as MilliporeSigma in the U.S. and Canada, has some 22,000 employees and 59 manufacturing sites worldwide with products focused on scientific discovery, biomanufacturing and testing services.

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New line of thermal packaging hits the market

Packaging Technology Group, Inc., a provider of thermal packaging for the biopharmaceutical and life sciences sector, has initiated a new line of off-the-shelf pre-qualified shippers, including an eco-friendly alternative.

As pharmaceutical manufacturers race to respond to the global health crisis with a vaccine, the need to protect any potential vaccine’s temperature tolerance remains a priority. The World Health Organization reports that up to 50 percent of vaccines are wasted each year, often due to inadequate temperature control in the supply chain.

The new off-the-shelf line includes small, medium and large shippers that all maintain a temperature profile of 2-8°C for 48 to 96 hours. Each shipper has a qualified design to perform in the summer and winter seasons.

The pre-qualified products are offered in four different insulating materials, including expanded polystyrene, cellulose, vacuum insulated panels and polyurethane.

The shippers in the cellulose line are 100 percent curbside recyclable and certified re-pulpable, so the entire box can be disposed of in a standard recycling bin. In addition, Packaging Technology reports that, to date, it has helped save roughly 400,000 pounds of expanded polystyrene from landfills.

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J&J and Europe agree on Janssen Covid-19 vaccine candidate, subject to regulatory okay

The European Commission (EC), acting on behalf of the European Union (EU) member states, has approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its Covid-19 vaccine candidate following approval or authorization from regulators.

The member states also have the option to secure up to 200 million additional doses, according to an announcement issued today by Johnson & Johnson.

The investigational Covid-19 vaccine leverages Janssen’s AdVac technology that was used to develop Janssen’s EC-approved Ebola vaccine regimen and is the basis for its HIV, RSV and Zika vaccine candidates.

The Covid-19 vaccine, if successful, is estimated at launch to remain stable for two years at -20°C and at least three months at 2-8°C, according to a September 23 company release that noted, “This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.”

The Covid-19 contract follows the conclusion of exploratory talks with the EC. The company said it is in ongoing discussions with other stakeholders, including national governments and global organizations, as part of its efforts to meet its commitment to make its vaccine candidate accessible globally, provided the vaccine has a good safety profile, is efficacious and receives approval or authorization from regulators.

Separate to the agreement with the EC, Johnson & Johnson also announced plans to allocate up to 500 million vaccine doses toward international efforts to ensure access for lower income countries, with delivery beginning mid next year following required regulatory acceptance.

The company is evaluating a single-dose regimen in its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) that started in September. A second Phase 3 study with a two-dose regimen is planned to start later this year.

Johnson & Johnson previously announced it has been scaling up its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year.

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Carrier cold chain initiative targets growing vaccine demand

Carrier Global Corp., a provider of cold chain assets and intelligence, has launched a program designed to help meet the rapidly evolving cold chain demands for advanced refrigeration technology to protect medicines, vaccines and food.

“The times we live in have increased the importance of cold chain resiliency and accelerated the need for more connected solutions from origination to delivery,” said David Appel, refrigeration president at Carrier.

The new Healthy, Safe, Sustainable Cold Chain Program focuses on four key health-related areas:

  • Medicine and food security measures that address refrigeration technology challenges from production to patient and farm to fork
  • Ensuring safety during temperature-controlled vaccine distribution
  • Employing digital technology to connect and enhance cold chain visibility and intelligence end-to-end
  • Reducing loss, waste and environmental impact across the cold chain

The company’s refrigeration technology monitors the safe transport of perishable medicine and food to support supply chain flexibility and product safety.

Carrier’s installed base includes 1.2 million transport refrigeration units, 50,000-plus commercial refrigeration installations and cargo monitoring capabilities for theft prevention, thermal mapping and logistics optimization.

Palm Beach Gardens, Florida-based Carrier offers heating, ventilating, HVAC, and air conditioning, refrigeration, fire, security and building automation technologies.

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Sandoz launches its first RFID-tagged critical injectable medicines

Sandoz Inc.’s first two injectable medicines featuring Radio Frequency Identification (RFID) tags will become available to U.S. hospitals beginning this month through a collaborative effort with automated medication management company Kit Check, Inc.

The medicines include Anectine 200 mg/10mL and Rocuronium 50mg/5mL and 10mg/5mL (paralytics to relax muscles during surgery or other medical procedures). The companies announced that additional Sandoz medicines are expected to be made available to Kit Check’s hospital partners through early 2021.

“Several products included in our collaboration with Kit Check are important hospital medicines that physicians rely on for immediate treatment of critically ill patients,” Carol Lynch, Sandoz president, said in a statement. “This aligns with our strategy to supplement our ongoing work through disruptive channels to ensure a reliable supply of high-quality injectable medicines makes it to hospital patients who need them.”

The move is intended to help hospital pharmacies reduce risk and better support patient treatment in hospitals by providing real-time inventory reports, timely tracking of expiration of products and recalls, and aid in automatic replenishment of supplies long-term, according to the companies.

Kit Check supplies RFID-based medication inventory tracking and automated tray processing at more than 500 hospitals in the U.S. and Canada. The tags are applied to vials, syringes, bags and other medication packages and supplies in trays and kits, and used to track each medication that passes through hospital pharmacies.

Both Sandoz and Kit Check are members of the newly formed industry consortium DoseID, launched in August 2020 to ensure standardization and interoperability of RFID in the pharmaceutical supply chain.

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Fresh perspectives on pandemic response

While still a “card-carrying pharmacologist” today, Dr. Nicolette Louissaint points out proudly, the trained chemical engineer, with an accomplished academic background in biological and molecular sciences, has always had a superseding draw to biomedical research in the context of finding solutions for broader populations. A drive Louissaint, currently executive director and president of health preparedness and response nonprofit Healthcare Ready, believes made her transition into the world of emergency response a natural one. “It’s understanding the integration of practical challenges that are faced by communities and patients with how best to create a science- and evidence-based-led response to address those challenges,” says Louissaint, whose initial work in this area focused on HIV and ways to ensure drugs for the disease could maintain thermal stability and be safely distributed.

More crises would come calling. During the height of the Ebola epidemic of 2014, Louissant served as the senior advisor to the US State Department’s special coordinator for Ebola. She joined Healthcare Ready a year later and assumed the leadership role in 2017. The organization supports supply chains through collaboration with public health and private sectors. Last year, Louissaint was appointed to serve on FEMA’s National Advisory Council. Also with experience in areas such as health IP, trade issues, and technology transfers, she recently earned an MBA from the University of Baltimore.

Pharmaceutical Commerce caught up with Louissaint to discuss the response to the COVID-19 outbreak.

 

1. Healthcare Ready has a history of responding to disasters like Hurricane Katrina; how has the COVID-19 pandemic played out differently?

One of the challenges that’s a bit distinct in a pandemic is that while the recovery phase for a catastrophic hurricane like a Katrina or even a Harvey, Irma, or Maria, that tail for recovery is quite long. However, when you’re thinking about a pandemic, the response window, the amount of time when you’re in active response, is extremely long. It’s a very intensive effort that involves a lot of coordination, a lot of deep focus and information sharing, And to sustain that level of engagement in response for months on end is exhausting. It strains partnerships, it strains capacities, but it also strains resources. It’s going to pull from the resources that we would normally use toward hurricane season or wildfire season.

Being able to shift resources from one region that may not have a pressing need to a region that has a greater need is a standard part of many of the emergency response plans that are in place. The complexity, however, is when you’re thinking about a pandemic where the need is global. It’s not quite as straightforward. Especially a few months ago, there were many parts of the world that were dealing with extreme strain at the same time.

I don’t know that I would say one [calamity] is necessarily worse than the other. The acute needs that result are acute needs and if you are a patient or a member of a community and you have been severely impacted, it doesn’t matter.

2. How involved is Healthcare Ready during events like these in making sure pharmaceuticals and medical supplies get to where they’re supposed to go?

That’s a big part of what we support—the coordination across the entire supply chain. As it relates to patients, first and foremost you’re thinking about who has been impacted by the virus itself, and the medicines that are going to be needed to treat those patients. In the case of COVID-19-infected patients, you’re not dealing with a therapy or a cure, but you are dealing with treatments that may be needed to help them recover.

One very clear example is ventilator usage. Those are painful devices, and when an individual is being ventilated, there are medicines that are typically administered to deal with the pain and with sedation and things of that nature. So you really can’t just have ventilators without having ventilator-associated medicines. Those are the types of things that you think about for those individuals who are actually fighting the disease itself.

3. How frustrating was it, particularly at the height of outbreak, dealing with the reported shortage of pain drugs for these patients ?

There were some spots shortages and some challenges, but there were also a number of substitutions and products that were ramped up in production or that were procured from generic partners, including international manufacturers, to be able to assist. What happens in a scenario like that is, while there are an abundance of ventilator medicines for a normal time, it’s difficult to predict that you would need ventilator-assisted medicines prior to the pandemic. It’s not a countermeasure, it’s an assisted therapy.

But then there was also focused effort on making sure both the primary and the secondary preferred medicines that were able to safely ventilate patients were being made available, and that there was continuity in the coordination and information sharing with federal government partners as well as with the manufacturers, the distributors, the GPOs, and the hospitals—so that there was visibility in what hospitals needed and what they were ordering. And, in addition, there was guidance and discussions with the federal partners as it related to being able to allocate and distribute the product that was available based on the number of COVID-infected patients and the actual immediate need. Also important was the coordination with manufacturers to make sure that production was being ramped up and that there was some sense of what would be needed to be able to overcome those shortages.

Other key roles for the pharmaceutical supply chain, especially, involve developing medical countermeasures and the process of developing potential vaccines and therapies, and making sure that the manufacturing plans will be able to develop those vaccines and therapies in a way that allows for the necessary surge, but also doesn’t hinder capacity to continue production of products that are needed right now.

In the midst of thinking about individuals who may be infected with COVID or might be infected in the future, we’ve also got to remember that there are a number of chronic care patients that have needs for medicines every day. One of the most important components of what the pharmaceutical supply chain has had to continue to do is ensure that the medicines that these patients need to remain healthy and manage their chronic illness are available to them. That is a major priority—making sure that we’re not so focused on just surging up production of therapies or vaccines related to COVID.

4. Do you think the industry/ healthcare systems have done a good job in addressing those patient needs?

I’ve been really proud to see the way in which our partners, both public and private, have come together to do everything, from the messaging, in a manner that allows for the type of information sharing, the type of access to advocates and partners and community organizations that can help ease the navigation for patients. Helping them understand what to do if you’ve lost insurance, for example. Thinking about things like emergency refills and even explaining the difference between hoarding and stockpiling and preparedness. How many refills should they have on hand at a given time? Can we figure out ways to expedite their ability to do mail order refills and things of that nature, and having an entire supply chain be prepared to support that surge?

Because when stay-at-home orders were coming in March, we saw a lot of patient rushing to their pharmacies to try to get those emergency prescription refills and figure out how much of their refill they could get. That puts a strain on the supply chain as well because of the number of individuals that are dependent on chronic care maintenance meds.

5. You mentioned the toll these coordinated efforts can have on partner relationships. Among distribution channels—manufacturers, wholesalers, retail pharmacies, FEMA, etc.—has there been a “banding together” type of mindset that has carried through?

Absolutely. It’s all about being able to coordinate and not just among competitors that are within the same part of the supply chain, but truly across the supply chain. There’s been a real desire that we’ve seen from manufacturers, distributors, GPOs, pharmacy partners, ancillary care health system providers, collectively, working together. Because some of it is about sharing what they’re seeing. How can we shine a light on our perspective so you know what we need, or we can explain the things that we need you to search on in a way that makes sense and was helpful?

That coordinated activity got most mobilized in February and March, and we’ve been able, from the Healthcare Ready side, support it. There’s definitely been a real spirit of partnership. I’ve seen partners across the supply chain lean into working together to tackle an issue more than the opposite.

6. As discussed, there was an initial reaction to the pandemic of higher demand for pharma products. How did distributors balance that need with making sure they were protecting their own workers and drivers?

One of the most important things that we’ve all had to remember is how much the situation has evolved. At the beginning of the pandemic, when we were thinking about stay-at-home orders and there were also some states that had geographical restrictions, requiring, basically, that if [distributors] go into the state or if they cross state lines or are near a hospital, they are required to then self-isolate or quarantine for 14 days. With that, you’re thinking about the challenges for distributors, especially not having enough drivers; they can’t afford for every driver to have to self-isolate after a single delivery or a day of deliveries.

So we had to work on everything from clarifying that type of a mandate or request in order to make sure that either there were exemptions that were in place for drivers or that it was clear how they were going to be able to monitor symptoms or what was truly being expected of them. There were a lot of discussions regarding [personal protective equipment]utilization based on the science of understanding what the appropriate level of PPE would be for a delivery driver if they are making contact with the hospital, if they’re delivering to a secondary site. Also what the appropriate disinfection and sanitation practices would be for a DC or warehouse. We did a lot of work making sure that we were sharing the information that became available from the CDC, but also that our distributor partners had an opportunity to review and ask very specific questions that would have been unique to distribution.

We wanted to make sure that as the response surged, that it was as easy as possible for them to know what was required. We needed to also, from our vantage point, make sure that we were educating our government partners to understand that we need federal, state, and local coordination on these issues related to DCs, specifically distribution, because there are many times where products will be moving across multiple states.

One thing that I saw all of our distributor partners do, which was commendable, was work with their customers to make sure that they had ironed out processes for what deliveries would look like, what the cadence of those deliveries would be, where the drivers were approved to make deliveries,  etc. The goal was to make sure that they were protecting their drivers but also protecting their customers. By having better control over that handoff and that actual worker protection, they were able to protect their workers and drivers in a way that I think made it much easier for us to sustain ongoing deliveries and distribution throughout the entire response.

7. Might these experiences and practice adjustments lead to a new business model in pharma distribution?

I don’t know what the future holds. There’s so much uncertainty right now. But I think what has been made clear is the capacity that the entire supply chain has, and the vastness of their resilience plans and the need to be able to have recovery and resilience plans that coordinate across the sectors. Everything from the way in which AmerisourceBergen worked with the federal government to help move [emergency-use drug] remdesivir at their direction, to the way in which GPOs like Premier were able to make sure they were coordinating and sharing insights they were getting at the hospital level with the federal government. It’s taking that insider capacity from the healthcare side, and using it to improve the way in which we’re taking care of communities and patients in response.

It’s important to remember we saw uprisings and civil unrest across the country in response to the killings of Breonna Taylor, George Floyd, and Ahmaud Arbery. We saw the need to maintain logistics in cities that may not have had an access and reentry point  for COVID, but did have a blockade up because of unrest and protests. Things  are happening at the same time, and it’s a reminder that you don’t have a plan or create a capability for just one type of hazard. What you do is make sure that that capacity can actually work across multiple hazards.

8. As preparation for the distribution of vaccines and/or therapies for COVID-19 ramps up, is there a preferred approach that Healthcare Ready supports?

What we support are around principles rather than a specific plan. We support making sure that science is guiding the distribution plan and that we are leveraging existing capacities to be able to move the product. We’re also supportive of the work that the National Academies is doing on behalf of the CDC to be able to determine equitable allocation and distribution of vaccines. That is a very complicated set of issues related to coordinating just how you determine across a range of ethical- and equity-based issues, how to allocate a vaccine once one becomes available and what principles should you use as a guide. We’re very supportive of the National Academies as they’re looking to help create some guiding principles and a framework for that.

Science will be the guide. As we learn more about the potential vaccines and we understand which are likely to be approved and then are ultimately approved, there will be a distribution plan that accompanies that. There are a number of partnerships that have been forged, even in assistance ramping up for production, which will certainly change the speed at which product becomes available and needs to be pushed out. We’re watching that all very closely.

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From pain to practice?

The global coronavirus pandemic has triggered fear that the global and extended pharmaceutical supply chain would crumble. In practice, it has proved remarkably resilient with drug shortages kept to a minimum, though the crisis has exposed weaknesses in the supply chain that must be addressed as the world recovers and prepares for what the future holds.

What has traditionally been viewed as a weakness of the pharma supply chain has actually proven to be one of its strengths. Lead times are regularly four to six months or even longer, reports state, ensuring some short-term resilience. However, should disruptions in the manufacturing of raw materials or active pharmaceutical ingredients (APIs) last for more than two or three months, a trickle-down effect could result that may have lasting ramifications globally.

The situation is even more acute for the global supply of medical products. The worldwide shortage of personal protection equipment (PPE) has demonstrated both the difficulty of meeting demand when the supply chain is under-prepared and the challenges in ramping up production and supply when there is pressure to deliver.

Here are a few supply chain lessons that pharma and medical product companies can learn from the COVID-19 pandemic.

Overreliance on few sources of supply. COVID-19 didn’t expose the industry’s overreliance on China and India for raw materials, APIs, and increasingly finished products. Instead, it has brought home what that overreliance can mean when faced with a global health crisis. For example, the US and Europe may be the two largest API manufacturers in the world, but China and India combined have a greater market share than both, and India is the world’s largest manufacturer of generics.

Any lasting disruption for these markets will have real impacts further down the supply chain. It is instructive to note that this impact doesn’t always come from direct disruption. For example, India temporarily banned the export of some generic drugs as the government was worried about shortages in its domestic market. COVID-19 has demonstrated just how real these supply chain risks are, and the need for pharma companies to, wherever possible, have multiple sources of supply spread across different geographies so they can quickly switch production from highly impacted to lesser impacted territories.

Security of supply is a matter of national importance. The pandemic woke up regulators and world leaders to the ongoing industry effort in the US and Europe to rebalance the pharmaceutical and medical product supply chains. In truth, this trend has been underway for some time. The US congress and the EU have debated the issues and had tentatively started to legislate to address the imbalance. Both governing bodies spoke openly about the need to safeguard the world’s drug supply from the vulnerabilities inherent in relying on any one region for a significant proportion of essential raw materials and APIs. The security of supply for medicines will be a major political issue and we can expect all governments to continue to develop local capacity and secure local supply.

Supply chain resilience means more complexity. Medical supply chains have only grown more complex as they have integrated many different types of organizations within them. The need to quickly select between suppliers in different markets and regions and expand manufacturing into new territories to satisfy the increasing demand of governments and regulators adds complexity.

Meanwhile, regulations such as the Drug Supply Chain Security Act (DSCSA) place added stress on how pharma works with partners, distributors, and logistics providers. Although we’re seeing some DSCSA exemptions to deal with the pandemic, resilience is required to meet track and trace, monitoring, and licensing requirements. To achieve this level of resilience, companies need to work harder and smarter to deliver full digitization to every part of their supply chain operations.

 

About the author

Ferdi Steinmann is a global industry strategist, life sciences, at OpenText. This article appeared online first at pharmexec.com, an MJH Life Sciences sister brand.

 

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3PL selection as part of product launch process

It might seem that in this world of distancing and delays, working with external partners would be one of the most difficult parts of launching a pharmaceutical product. When it comes to third-party logistics providers (3PLs), however, who are one of the first distribution decisions for manufacturers to make, that doesn’t seem to be the case.

Since decisions about 3PL partners heavily impact state licensing strategy, it’s important that manufacturers move quickly and think ahead on this step. And because this has always been my preferred approach in working through the supply chain process, I’ve found that 3PL partners can show a significant amount of flexibility in how they approach RFPs, introductory calls, capability presentations, and audits. Today, adding in the need to make all of this remote, 3PLs have continued to remain engaged and responsive as we work to define timelines in this world of uncertainty.

Benefits of 3PLs

Before discussing best practices for selecting and working with a 3PL, it’s important to understanding the alternative, and then why many virtual manufacturers choose to work with 3PLs. Instead of using a 3PL partner, another option would be to go direct to wholesale from the CMO. For companies who choose this option, I would argue that they aren’t seeing the full picture of what a 3PL can do for them. People often think of them as only helping with picking, packing, and shipping, but if you find the right partner, they are so much more than that. Of course, there are variations in needs depending on what distribution channel the product is intended for—widespread generic to retail pharmacies, specialty to clinics or hospitals, direct delivery to patient, etc. —but across the board, some of the benefits of working with a 3PL are that they:

  • Reduce the legwork for state licensing by allowing virtual manufacturers to operate under their licenses.
  • Provide leverage and convenience for buying power and rates for freight, packing, and shipping supplies by passing their costs to the manufacturer at a nominal markup.
  • Provide full order-to-cash functions, managing accounts receivable, data management and reporting, invoicing, chargebacks, returns, etc. This support is valuable for manufacturers who are often working with lean resources and manpower.
  • Provide storage for the large product lots they are producing, avoiding the need to lease extra storage space or sell to the rate of production, which is usually not feasible.

Selecting partner

For manufacturers who are still looking for their partners, it was always best to conduct an on-site visit when possible, since that’s the best way to assess cultural and value alignment. For obvious reasons, this is no longer option No. 1. As a result, companies have had to figure out how to translate the personable experience of an on-site visit through a computer camera.

On the 3PL side, many vendors and partners have been very intentional about putting their own spin on the process to make it come to life. They bring in all the subject matter experts that are relevant to the project (which was more difficult when we were all traveling), so that the client can get answers to their questions and meet everyone involved. I’ve seen one 3PL bring in a cameraman to show the process of picking and packing a product, which added significantly more value than pre-taped footage, as it allows for the opportunity for live questions and interaction. Another potential vendor sent samples of validated packaging out to the customer.

For those in the process of selecting 3PL partners ahead of  launch, the first priority would be to keep the process moving forward since it will have an impact on your state licensing strategy. Virtual manufacturers often don’t physically touch their products, so many states take the stance that it’s the 3PL that needs the license since they are handling and shipping the product. Therefore, many state licensing applications require manufacturers to list its selected 3PL—some even require a copy of the letter of intent or a fully executed contract—to prove that an adequate handler is in place.

For manufacturers with existing arrangements with 3PL vendors, the most important thing to prioritize is regular, open, and transparent communication. Your partners should be providing you with business updates, COVID-19 impacts, CMO import statuses, and carrier updates.

Virtual audits

Amid the COVID-19 pandemic, many manufacturers have delayed official audits until it is safer for them to conduct an on-site visit. In these cases, they may sign a letter of intent that includes a contingency of having a successful on-site audit. This allows for contracting and implementation to move forward, but still protects the manufacturer from being locked into a contract without having all the process knowledge and quality signoff it needs. For this to happen successfully, it helps for the 3PL to be over-communicating about the dates that they expect to reopen for in-person visits. Doing so allows for the manufacturer to proactively schedule a visit, and for the 3PL to prioritize visits from different customers based on their product launch dates.

There is also the option of selecting virtual solutions to reduce the in-person components of the audit. Some of these include quality questionnaires, secure data rooms for SOP review, and virtual audits. During this instances, how a virtual solution might play out is largely dependent on the comfort level of the manufacturer.

Attention to detail

In today’s increasingly challenging and uncertain product launch landscape, it is critical for 3PLs to maintain flexibility in service support. Many biopharma companies are performing labors of love to keep their products moving toward launch and require a partner to match their dedication. Ask questions, and show your ability to provide customized solutions. It’s not easy to convey passion and commitment virtually, but this can be the biggest differentiator in a competitive market.

In many ways, while operating in a virtual world isn’t ideal, this is a great time to vet partners on how they work in a crisis. The industry today is seeing, in real-time, which companies are able to rise to the occasion and optimize their processes to be as flexible for a product launch effort as possible. Many have responded to selection times shortened from the traditional four months to two months. They have also allowed clients to begin implementation earlier to ease concerns about current uncertainties. My trust in this space has only increased as I’ve watched organizations change and evolve to serve customers in this unique and difficult time.

About the author

Jessica Randolph is Senior Account Director for Commercialization for Two Labs 

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RFID tagging is back for pharma traceability—for real

According to its press release, DoseID is “the first member-driven industry consortium for the use of radio-frequency identification (RFID) technology in the healthcare space.” That statement is debatable on several levels, in that RFID is being used for, among other things, asset management for hospital equipment—but let’s not quibble. The announcement appears to bring together several trends that collectively, could make RFID a preferred vehicle for serializing pharma products, at the item level, and providing not only compliance with the Drug Supply Chain Security Act (DSCSA) but also operational benefits in hospital pharmacies and elsewhere.

DoseID lives at Auburn University, where Dr. Bill Hardgrave, SVP for Academic Affairs, founded the RFID Lab, within which a function called the ARC Lab has provided certification for RFID applications in retail and aerospace over the past 15 years. Fifteen years ago happens to be around the time when pharma manufacturers and distributors began experimenting with RFID item-level tagging, but over the next 3-5 years the technology was mostly abandoned in favor of 2D barcoding. Today, nearly all newly manufactured pharma packages have those barcodes, and under DSCSA mandates, pharma products will be tracked from the factory to the pharmacy by 2023.

Founding members of DoseID include Omnicell Inc., Sandoz, Baxter, Hikma, Nephron Pharmaceuticals, Avery Dennison, Kit Check, MPI Label System and CCL Healthcare. Kit Check, notably, has been deploying RFID tagging for drugs used in hospital pharmacies, and participated in the recently concluded FDA Pilot Program for DSCSA advances. According to the company, more than 75 million dosages have been tracked within 500 hospital customers using its technology.

“Sandoz is committed to driving innovation that improves access to medicines, and we encourage the industry towards RFID technology. We believe this will be game-changing in the hospital setting, and we are proud to be at the forefront as one of the founding members of DoseID,” said Carol Lynch, president, Sandoz, in a statement. “This collaboration uniquely fits with our goal of creating strategic alliances to ensure patient access to critical, high-quality, affordable medicines when they need them.”

Beyond compliance
Significantly, DoseID participants see operational values that go beyond DSCSA compliance, at least in the hospital setting. These include reducing medication errors, ensuring expired product is not dispensed, and further automating pharmacy practices. Kit Check touts the fact that when its tagged product is included in the med-surg trays used in operating rooms, unused (but unexpired) dosages can be safely re-kitted, cutting pharmacy waste.

A foundational aspect of DoseID is to create standards for performance and interoperability among RFID device makers, label converters, and IT solution providers that would generate or store serial data. Within the ARC Lab, a set of standards on how RFID devices can be analyzed for quality and performance have been developed (and the ARC Lab can perform this testing). The consortium’s website makes reference to GS1 EPC standards (a basic step followed by most organizations involved in DSCSA compliance today), but also indicates a desire to go beyond them in order to accommodate other types of product information. A somewhat startling element of the DoseID standards effort is to have a master data repository as “the central database that all members can access to create new serialized items, log events and view an item’s history.” Such a one-off, centralized repository for the entire industry has been the bane of many, many DSCSA discussions over the years: a significant part of the pharma industry will resist enabling all its traceability data to be stored in this manner.

Another key question (and we’re surely getting ahead of ourselves here) is how the consortium forming up around DoseID will interact with the Partnership for DSCSA Governance (PDG), a less-than-one-year-old group whose mission is to help establish interoperability among pharma supply-chain participants. Two industry groups with the same general goal, but non-overlapping members, usually spells trouble for both.

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US Covid-19 vaccine distribution will start with McKesson

Saying it is “expanding an existing partnership with the Centers for Disease Control,” the Irving, TX firm has announced its designation as the “centralized” distributor of future Covid-19 vaccines. “We are honored that the U.S. government has asked McKesson to play a key role in the effort to distribute COVID-19 vaccines,” said CEO Brian Tyler in a statement.

In all likelihood, multiple other distributors will be involved as well, possibly as vaccines are cross-docked from McKesson facilities to those of other distributors. That is the pattern for the seasonal flu vaccine, where nearly 200 million dosages move rapidly into hospitals, clinics, retail pharmacies and public health facilities each year. One complication of the Covid-19 process is that some or all of the vaccines will require refrigerated (or possibly deep frozen) storage and transport—it depends on which vaccines ultimately are cleared for administration.

McKesson has been the lead distributor of the CDC’s Vaccines for Children Program (VFC), based on a competitive 2016 contract award. VFC provides vaccines for Medicaid and other underinsured children.

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Now, ‘freezer farms’ for potential Covid-19 vaccine delivery

Pharma logistics providers have long experience in cold chain management—generally, keeping pharmaceuticals at 2-8°C during storage and shipment. The push in recent years for cellular and genetic therapies, which can involve live cells, has created a growing need for so-called deep-frozen storage: -80°C or even -180°C (requiring liquid nitrogen). Now, it appears that at least some of the coming capacity surge for Covid-19 vaccines will require deep-frozen as well.

According to a recent Bloomberg News story, UPS is building “freezer farms” in Venlo, Netherlands and Louisville, KY (both near UPS air hubs) featuring banks of -80°C freezers (see photo). The farms will contain a total of 600 freezers that can each hold 48,000 vials of vaccine, according to Bloomberg News. Additional freezer capacity will be installed in South America, Germany and the UK.

“Moving parcels with dry ice and critical drug product is not a new thing for UPS. Transportation is our bread and butter,” Wes Wheeler, president of UPS Healthcare and Life Sciences, told Bloomberg. “Storing at -80, blast freezing at -80, making sure that time and transit is reduced to a minimal amount, all that is pretty new to us.”

While there is no mention of what vaccine UPS is preparing for, the -80°C specification would presumably not be suitable for various vaccines based on deactivated viruses, which typically require refrigeration but not freezing. The mRNA vaccines being developed by Moderna, Pfizer and others, however, likely do require freezing to keep the mRNA proteins viable prior to administration. (On the other hand, a freezer that can reach -80°C can also hold a warmer, but still refrigerated, temperature.)

In a related announcement, DHL Global Forwarding, the air and ocean arm of DHL, has just opened a 20,000-sq.ft. facility in Indianapolis, dedicated to life sciences and healthcare logistics. The facility has temperature-controlled storage at 15-25, 2-8 and -20° temperatures, and is within a Free Trade Zone, allowing for international cross-shipping. The facility “expands our global network for the LSH sector [which is] especially important now during these challenging times, when temperature controlled logistics is crucial in helping customers navigate the pandemic,” said David Goldberg, DHL Global Forwarding, US.

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Pharma Logistics’ grand opening of its reverse-distribution center

Pharma Logistics has officially opened its new reverse-distribution center in Libertyville, expanding and combining previous operations in Mundelein and Libertyville, IN.

Part of the growth opportunity comes from the October 2019 acquisition of the pharmaceutical reverse-logistics business of Stericyle, a major player in medical waste and reverse logistics. Pharmaceutical reverse logistics was valued at $13 billion annually in a 2018 HDA study.

Reverse logistics includes product recalls and the larger business in product returns. Typically, pharmacies return unsold or overstocked inventory, and wholesalers sort the returns for saleable items or those that must be disposed. Reverse logistics providers supplement those operations, or work directly with retail pharmacies to recover product. Pharma Logistics says that its client base includes hospital pharmacies, the Department of Defense and Veterans Health Administration, independent pharmacies, pharmacy chains and physicians’ offices.

An important element of Pharma Logistics’ service is to speed up the refund process by which manufacturers or wholesalers credit the pharmacies; the company says that it cuts that turnaround from months to a couple weeks.

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Sonoco ThermoSafe will sponsor an industry-wide cold-chain blockchain

For several years now, various players around the logistics of temperature-senstive pharmaceuticals have looked into blockchain technology, and some have adopted blockchain-like features in their data-handling systems. Now, one of the leading providers of cold-chain packaging—Sonoco ThermoSafe—is plunging in with both feet. The company has partnered with IBM to set up what will be called the PharmaPortal platform, and the stated goal is to develop a vendor-neutral to “to trace assets across many different supply chain participants, record a single version of the truth on all events generated on a package’s journey, integrate this data with that of other businesses across an industry-scale network, and provide access controls to help ensure each data owner maintains control over who can access it on the network,” according to Sonoco.

IBM has invested heavily in blockchain for the past several years, mostly involving HyperLedger Fabric, one of the version of blockchain that supports “smart contracts” (a way to have self-acting files or documents that could, for example, complete a sales transaction when the correct data has been provided). Around 2017, it announced the IBM Food Trust, which now has over 200 member organizations that share data on the provenance, quality and status of food products in a supply chain.

Paul Chang, global industry lead for blockchain at IBM, says that the company’s “production scale” developmentof blockchain, enables a relatively fast ramp-up of capabilities, including cryptography for protected messaging, permissioning of participants and other services. A built-in feature of IBM’s implementation is GS1-standardized messages, such as GLN (Global Location Number) and EPCIS, a framework to record supply chain events. (Pharma supply chain managers involved in compliance with the Drug Supply Chain Security Act will recognize the value of these GS1 standards, which are state-of-the-art in that application.)

Unlike IBM Food Trust, however, Sonoco ThermoSafe is setting up PharmaPortal to be governed separately from IBM; according to Christopher Day, director, marketing and innovation at Sonoco ThermoSafe, PharmaPortal will eventually be governed by its members. In blockchain-speak, Sonoco is the “convener” of what will become a “permissioned network” (meaning that only credentialed organizations can be members).
Data is the product

Sonoco’s PharmaPortal, as innovative as it promises to be, is only one of many approaches to cold chain tracking. Longtime US and international standards have required pharma cold-chain shipments to be monitored, even in transit from one location to another; now blockchain promises to make this data sharable to trading partners In recent months, two companies, va-Q-tec and SkyCell, whose products partially overlap with Sonoco Thermosafe’s, have ongoing blockchain-related projects. Among logistics providers (for all countries and industries) there is a Blockchain in Transit project. Meanwhile, a variety of telecom solution providers are offering systems and software to manufacturers to collect their own shipment’s operation and performance, in some cases duplicating the data collected by the container provider or by the freight forwarder. If the interoperability issues common in tracking the identity of drug shipments (DSCSA compliance) is any indication, the industry is heading for multiple blockchains an multiple interoperability issues..

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Pandemic drug distribution: dealing with a ‘slow motion hurricane’

Following right behind the intense buzz around vaccines for Covid-19 is the buzz for how approved vaccines (and therapies) will get to 330 million American patients overnight. That is, of course, an oversimplification: sufficient product won’t be available all at once on one day and, if precedents are followed, there will be some type of preference, for healthcare workers first and others coming behind. In whatever manner this is worked out, the next step will be physically moving product from manufacturing sites to clinics or pharmacies to administer to patients. And for that step, says Paul Dickson, president of Morris & Dickson drug distributors, the summary feeling is, “No problem. We (US distributors) do this all the time.”

Dickson says that there are two important precedents for dealing with the coming tsunami of drug demand: how the drug-distribution industry (and Morris & Dickson in particular, being based in Louisiana) learned from the Katrina hurricane in 2005); and the business practices it has established to deal with the annual runup to flu season as well as customary product launches. How drug distributors make a difference, says Dickson, is that they are already plugged into the majority of dispensing outlets (hospitals, pharmacies, long term care, alternate care, etc.). Based on demand, products are delivered to those outlets daily, and distributors know how to handle both surges in demand and shortages of supply through a variety of allocation processes.

Katrina was a wakeup call for the entire industry: once a region of the country was shut down and residents displaced, getting needed medicines became a crisis. (One outcome of Katrina was the creation of HealthcareReady, a cross-industry collaboration to identify critical needs and coordinate delivery.) The State of Louisiana turned to Morris & Dickson to figure out how to resupply the healthcare system across the region, and its trucks were quickly on the move.

“FEMA [the Federal Emergency Management Agency] has been used to draw product from the Strategic National Stockpile for emergency response,” says Dickson, “but in the case of Katrina, they were geared up to deliver trauma materials, while what patients really needed was their daily blood-pressure medication,” he says. In the aftermath of Katrina, the state of Louisiana developed a longterm arrangement with Morris & Dickson, whereby the company keeps a stockpile on hand for emergencies, and can distribute them quickly and effectively where they are needed. “We know where the health centers are and how to deliver to them, and we can manage the inventory to keep fresh product on hand,” he says. “The Strategic National Stockpile can’t do that.”

Morris & Dickson, whose roots in Louisiana go back to 1841, is generally regarded as the No. 4 distributor in the US, behind McKesson, AmerisourceBergen and Cardinal Health (as it is privately held, its revenues are not publicly reported). It operates throughout the South and much of the Midwest. In addition to being M&D president, Dickson is on the executive committee of the Healthcare Distribution Alliance.

Gearing up for Covid-19
In Dickson’s view, his company—and the rest of the distribution industry—can take lessons learned from Katrina and apply them to the ongoing pandemic. “The response to Covid-19 has been just like responding to a hurricane, only in slow motion,” he says. Drugs for patients on ventilators or with respiratory disorders suddenly skyrocketed in demand, and the industry had to figure out both how to increase supplies and get the products to where they were most needed.

Gilead Sciences’ remdesivir, as a newly identified treatment, represents something of an intermediate point between pre-pandemic and when vaccines will be available. A set quantity of the drug was made available by Gilead (and was distributed to states by AmerisourceBergen); now production is ramping up and the drug will flow into the industry’s distribution centers.

HHS sent out a request for proposals for how to distribute vaccines in mid-June, and M&D was one of the organizations who responded. Its proposal emphasizes a “public/private partnership” in which vaccines (and other products in the Strategic National Stockpile) are distributed from the national network of wholesaler distribution centers. Somewhat controversially, the company recommends using only the Top 3 distributors plus M&D—something that would leave numerous small distributors out of the mix. In essence, M&D is recommending that the arrangement it has with the State of Louisiana be expanded to other states, and with more distributors. Data on both health system demand, and available supply, would be centralized and reported to HHS, which could intervene to reallocate dosages.

There are parallels with how flu vaccine shipments have been handled (coincidentally, the distribution system is gearing up right now for flu season with an expected 168 million dosages eventually to be distributed during the flu season that begins in October). Flu vaccine goes from manufacturers to wholesalers, while a supplementary effort is conducted by the Centers for Disease Control to make vaccine available late in the season where needed. Additionally, both one of the two forms of remdesivir (the injectable) and just about every currently publicized Covid-19 vaccine in development are cold chain products, requiring refrigeration during transport and storage.

It’s worth noting, says Dickson, that with the exceptions of shortages of personal protective equipment (PPE) and drugs specific to Covid-19 treatment early on as the pandemic took hold, the US pharma distribution system held up reasonably well—there were few reports of empty pharmacy shelves (unlike, say, grocery stores). “There’s a lot of hyperbole in the media that when a Covid-19 vaccine becomes available, we won’t have the resources to distribute it efficiently,” concludes Dickson. “We know how to do this, and we’ve been doing it for a long time.”

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Survey sees continued drive toward more sustainable cold-chain packaging solutions

For several years now, Pelican Biothermal has been promoting the use of reusable, high-performance packaging in cold chain shipments; to this end it has established a global network of sales, service and return-logistics offices. (The company also sells single-use packaging.) Now, in its latest annual survey, it finds that 89% of pharma managers polled rate meeting sustainability goals “important” to “very important.” This has translated into “a steady uptick” in use of reusable packaging, acquired (in 2019) by 39% of those polled, with 25% more “exploring” the option.

“Five years in, the pharmaceutical industry and its cold chain logistics partners have been slower than most to prioritize sustainability in business and operational strategies,” the report notes. But the pace might be picking up: the survey found that 52% of respondents were being audited for their sustainability practices (and an even higher percentage were auditing their suppliers).

Pelican Biothermal—and others—have made a pitch that, when a full-on packaging-reuse program is in place, its total cost of ownership can beat the cost of single-use packaging, with the added assurance of better protection for temperature-sensitive shipments.

The Pelican survey is available here.

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Spinning up the pharma traceability wheel

There are centrifugal and centripetal forces carrying along the drive toward pharma traceability today: forces that bring the pharma supply chain into a more united and cohesive effort (centripetal); forces that are sending supply chain participants in different directions (centrifugal). And while much of the US industry is continuing a drive toward compliance with the Drug Supply Chain Security Act (DSCSA), passed in 2013 with a highly unusual 10-year implementation schedule, technology—and the vendors advancing technology—have continued to evolve, creating new opportunities for tracking the movement of pharmaceuticals throughout healthcare, or for preventing counterfeiting of drugs (one of the original objectives of creating DSCSA).

Industry progress had been advancing, if by fits and starts, when the global pandemic hit. Now, many industry experts expect that deadlines for various compliance milestones will be delayed by a year or more; the 2023 deadline for full DSCSA compliance is already expected to move to 2024.

Here are a few of the unifying (“centripetal”) forces:

●The successful establishment of the Partnership for DSCSA Governance (PDG), a voluntary collaboration to bring manufacturers, distributors, pharmacies and health systems together to solve end-to-end supply chain issues with DSCSA compliance. PDG originated with some of the same people who founded the Pharmaceutical Distribution Security Alliance (PDSA) as DSCSA itself was being written. PDG is up and running, and various members are engaged in workgroups for interoperability and credentialing, among other goals.

●The heavy lifting to meet DSCSA requirements for verifying returned product. DSCSA rules mandated that US wholesalers be able to verify the authenticity of returned product before it is put back into distribution; the technical means to do this has come to be called a Verification Router Service (VRS). As it turns out, creating a VRS that enables (in a perfect world) any possessor of returned product to verify its source is an exercise in full DSCSA compliance, at a micro level. In effect, VRS has become a pilot study for DSCSA functionality.

Here are some diversifying (“centrifugal”) forces:

●Hospital dispensing and the return of RFID. The pharmacies at health systems are finding increased value in their own identification and tracking processes inside their systems, and in some cases are using radio-frequency identification (RFID) technology to do so. This creates the prospect of one system for DSCSA compliance and another for internal tracking—a potentially duplicative and divisive element of overall traceability.

●The advancement of traceability in other industries. Both before and during the 2013-2023 rollout of DSCSA, other industries, notably food and consumer goods, have been advancing their own traceability initiatives. In some cases, advances in those industries will help move pharma traceability forward; in other cases, it creates potential conflict. The role of the GS1 global organization (which sets standards for, among other things, barcoding of commercial goods) will be key in keeping various players more or less on the same page. Another aspect of this is that some key pharma-traceability vendors are now eying these other industries (good for their business plans, bad for pharma if the focus shifts away).

Pharma traceability is a global undertaking—not only for manufacturers outside the US sending products into the US, but also for traceability and authentication efforts in 40 or more countries for their own internal markets. In the past year, much attention was paid to Russia, whose traceability systems are now coming online, and attracted the efforts of traceability vendors in the US and Europe. Brazil is also in this about-to-start-up mode. The European Union’s Falsified Medicines Directive (FMD) is now operational, to varying degrees of success, throughout the EU.

VRS becomes real
With fingers crossed, wholesalers in the US are readying their systems for verifying the authenticity of product returns, which represent several billion dollars’ worth of inventory for them. This regulatory milestone was to have been enforced in November 2019, but FDA delayed it for a year. According to industry sources, efforts were proceeding smoothly for industry readiness at the beginning of this year—then the pandemic struck. Getting a VRS system operational cannot be performed remotely; distribution center workers need training and equipment, but travel restrictions have slowed down the ability to do that gearing up. The hope is for a further delay at FDA (who, it is expected, will have its own difficulties in sending out inspectors come November).

The technical issues, to a large degree, appear to have been solved. Based on developmental work by the Healthcare Distribution Alliance (HDA), wholesalers and manufacturers have settled on a system where traceability vendors create a lookup directory (LD) of their clients’ product information, and the vendors ensure that their various repositories can communicate with each other. Then, when a request for validating a product return comes into one vendor, that LD routes the request to whichever vendor has the relevant manufacturer information. Ultimately, the request shows up at the appropriate manufacturer, who verifies the product identity. All of this needs to occur within milliseconds.

Wholesalers have had two tasks over the past couple years: setting up a VRS for the products they handle; and getting manufacturers onboard to be able to respond to a request. The VRS interoperability project was also an element of the FDA DSCSA Pilot Program (see below); technology vendor Rfxcel worked with an engineering-consulting firm Vantage Solutions, to run the interoperability tests, demonstrating the feasibility of the routing network. Work is proceeding on both tasks during the course of this year.

The process of verifying saleable returns involves a part of the pharma supply chain: wholesalers, manufacturers, and solution providers who offer a VRS system. Broader DSCSA compliance will bring in retail pharmacies and health systems—and they have a nominal November deadline for being able to verify the authenticity of incoming pharma products. According to industry sources, progress has been made at many health systems, but is lagging at chain pharmacies, and is nearly hopelessly lagging at independent pharmacies (some of whom lack basic internet access). A possible workaround is that the wholesalers supplying independent pharmacies will be able to provide both verification and reporting capabilities to their pharmacy clients—but the success of that remains to be seen.

FDA pilots
The DSCSA law mandated that FDA perform pilot studies of technology and business processes, and that effort kicked off in the spring of 2019 with applications being submitted, and a final list of projects issued by FDA last summer (see Fig. 1).

FDA DSCSA pilot list

Fig. 1 FDA’s list of accepted pilot projects for DSCSA testing.

The list was quite diverse in goals and capabilities. FDA intentionally sought out broad representation, including large and small pharma manufacturers, a variety of solution providers, and various pharmacies. (The involvement of chain pharmacies, except for participants in group discussions, was notably missing.) The creation of PDG was itself a “pilot;” and there were some projects in the works already, such as the HDA VRS effort, which got merged into the Rfxcel-sponsored FDA pilot.

All of these projects were to have been completed in early 2020 and reports filed with FDA. Some of the companies involved provided a report for public viewing; some issued a press release. Pharmaceutical Commerce obtained several of these reports and news releases; at presstime, some of these projects were to be part of an online presentation by PDG (who might then archive them for public viewing). At some point, FDA is supposed to issue a comprehensive report on lessons learned.

Some highlights:
●Cardinal Health ran a study of DSCSA information it had received from manufacturers, contract manufacturers, repackagers (including its own business unit), other wholesalers. The goal was to evaluate how closely all participants are adhering to EPCIS standards (which have been developed by the GS1 organization). Results were troubling: only 28% of records could be accepted as is.

For the most part, the exceptions were resolvable, involving such details as events out of sequence (i.e., a shipment notification being dated before a commissioning notification); inappropriate GLNs (Global Location Number—another GS1 standard); or missing data.
“Given the volume of products involved and in order to avoid interruptions in patient care, it is important that there be ways to distinguish these commercially routine exceptions (transmission and aggregation errors) between established trading partners from true suspect or illegitimate product situations,” concluded the report.

●KitCheck demonstrated its compatibility with DSCSA goals in the hospital-tracking systems it has already commercialized. The company provides RFID tags which are applied to incoming pharmaceutical products at hospital pharmacies, as well as a cloud-based data repository for the data. Hospitals can then track the drugs as they move through the facility, including those that are included in med-surg “trays” (kits). According to the company, being able to track those kitted drugs enables hospitals to retain them longer (as opposed to throwing away all the contents of the kit, once it was opened), as well as to track its inventories more closely.

The company has also had notable success in helping hospital pharmacies control the dispensation of controlled substances. Some 500 hospitals are already using a KitCheck system.

●The IBM/KPMG/Merck/Walmart group, which has called itself the “Pharmaceutical Utility Network (PhUN),” demonstrated that blockchain technology can be used to record product movements, and to initiate an alert for an investigation or recall. The testing did not, however, involve actual product movements. IBM is heavily involved in developing Ethereum-based blockchain projects, and has run what is called the IBM Food Trust for providing traceability in food production.

MediLedger blockchain

Fig. 2. MediLedger’s vision of a network that provides both DSCSA compliance and communicates business transactions. credit: MediLedger

●The MediLedger project, which involved that blockchain company, plus 25 organizations in the pharma supply chain (members of a consortium that has been coordinating blockchain development since 2017). Among other things, the pilot demonstrated the feasibility of MediLedger’s Ethereum-based technology to exchange messages; the company calculates that a full-blown, national system will require at least 856 transactions/s to be communicated.

●The BruinChain project, spearheaded by another blockchain company, LedgerDomain, demonstrated the ability of its HyperLedger-based blockchain technology to track deliveries into the pharmacies of the UCLA Health System. This was one of the few actual pilot projects, in the sense of performing real-world testing (the project involved tracking deliveries of Spinraza, a Biogen product). Among other findings, the project revealed that “white-bagging” (the shipment of a drug from a manufacturer directly to a healthcare provider, rather than distribution from a wholesaler to a pharmacy) complicates product tracking: since a wholesaler wasn’t involved, someone else (the manufacturer or the manufacturer’s agent) needs to document transaction history.

What FDA will make of all this is unclear, which is not to say that the pilot projects were a wasted exercise. Many of the conversations that occurred among project participants are a preparation for how the industry will deal with the march to full DSCSA compliance. It is notable that several of them involved blockchain technology, which holds the promise of providing “immutable” records of transactions—a goal of DSCSA; the general drift of blockchain discussions is that private blockchain networks will eventually be set up, and then the challenge becomes how these networks will interoperate.

Whether the future of pharma traceability is blockchain-based or not, the ability to identify who is requesting or providing transaction information will need to be established. That, in turn, points to the “governance” of the networks—and that is where PDG comes in. The eventual goal is to be able to verify “authorized trading partners” among whom information can be exchanged.

Excellis Health tracking service

Fig. 3. Excellis Health’s Alert Management Service, which tracks incoming tracking messages for manufacturers or distributors. credit: Excellis

These pilots are by no means the totality of what has transpired in the past year in DSCSA compliance. LSpedia, a solution provider, has just announced the newest generation of its technology. TraceLink has announced the introduction of the Opus Network, an architecture that is intended to allow third-party developers to offer software to make use of the extensive data it holds for its hundreds of pharma clients. Multiple vendors, including Rfxcel, Movilitas, Covectra, Adents, Antares and others have VRS offerings. Axway and VAI have partnered with LSpedia on a VRS offering. Sovereign Pharmaceuticals, a Fort Worth, TX, contract manufacturer, has installed an open-source traceability system, Qua4rtet, working with Vantage Solutions to implement.

Meanwhile, business is growing for ancillary software to manage the installed base of traceability systems. Excellis Health is offering an alert management system, to enable DSCSA messages (such as saleable return queries) to be tracked to resolution. Gateway Checker Corp. is offering a same-named product to perform conformance checking on EPCIS messages. LedgerDomain has expanded its data repository, and provided a smartphone-based interface, to check product details based on FDA records.

Overall, the outlook for industry to meet DSCSA deadlines (whether by 2023 or 2024) looks positive—but much more work remains to be done.

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DHL Supply Chain boosts its US life sciences investment by $70 million

Having committed $150 million to life sciences resources in the US in 2019, DHL Supply Chain is upping its ante with a new round of investment, totaling $70 million. Expansions are planned at Las Vegas, Memphis and Indianapolis, plus two other undisclosed locations; total 2-8°C storage capacity is rising from 12,000 pallets to 15,000, and overall storage capacity is rising by 1 million sq. ft. Additionally, the company is investing in more automation and IT, including expanded e-commerce capabilities and robotic devices on the warehouse floor.

One of the drivers of the current round of expansion, says David Kopstein, VP of Life Sciences & Healthcare, DHL Supply Chain North America, is that manufacturers are expanding their inventories of both ingredients and finished product, necessitating more storage capacity at logistics providers. DHL Life Sciences includes pharma, med devices and OTC products; recently the company also announced a 10-year relationship with Siemens Healthineeers, providers of medical imaging equipment, diagnostics and other products, for sales and service.

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United Cargo, DSV and Va-Q-Tec combine for frozen plasma delivery

United Cargo says that it has been working with logistics partners to deliver approximately 35,000 lb of blood plasma, weekly, among a variety of international locations during recent months, despite the difficulties in air freight created by the Covid-19 pandemic. (While some of the plasma might be intended for Covid-19 patient treatment, this is apparently not the sole application.)

Besides employing United Cargo planes, the shipments involve DSV Air and Sea (a unit of Denmark’s DSV Panalpina A/S) which includes warehousing and ground transportation, and va-Q-tec, suppliers of the TWINx shipping container (pictured). The shipments are delivered at -20°C in the TWINx containers, which use va-Q-tec phase-change materials capable of operating between -70 and 25°C (depending on the type of PCM in use).

United Cargo boasts that it has kept a “commercial air bridge” open globally during the pandemic, having made 3,500 cargo-only shipments between the US and over 20 cities globally during the mid-March to mid-June period. In late April, it also announced that it was the first US carrier to make the Opticooler RAP unit (which can hold up to five Euro-size pallets) available to clients as part of its TempControl service. Opticooler is a product of DoKaSch Temperature Solutions.

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How to ensure conformance to EPCIS standards in drug traceability

Within the next 30 months, some US pharmaceutical wholesalers are planning to be traceability-ready in accordance with the Drug Supply Chain Security Act (DSCSA). To some that might sound like plenty of time. To those of us with years of experience in the industry, it sounds more like a sprint to the finish line rather than a pleasant jog.
Even now, the US drug supply network is struggling with electronic, interoperable traceability without alignment around a common set of application standards. A report from the Office of Inspector General of HHS, while evaluating the current status of DSCSA traceability, recommended that “FDA offer educational outreach to trading partners about required drug product tracing information and data standardization guidelines.” [1]

There is a broadly (but not universally) accepted standard for trading-data communication: the EPCIS standard of the GS1 organization. But to ensure that EPCIS is being effectively employed by pharma trading partners, and the software vendors serving them, a testing protocol has been developed and sanctioned by GS1. This article will explain its justification and application.

Supply chain events
Drug traceability captures transaction events as individualized medicine containers and their parent cases travel from manufacturer to the point of dispense. By aggregating these events, regulators can understand location history, who has handled the product and for what purpose. FDA wants to ensure that only legitimate, uniquely identified product moves through the supply chain and that it is being handled by legitimate, licensed, and authorized trading partners.
To attain electronic, interoperable pharmaceutical traceability, each member of the drug supply network must connect and exchange information sufficient to enable supply chain transparency and integrity.

GatewayChecker Connectivity

The US pharma supply chain has thousands of interconnections.

In fulfilling more than 25,000 prescription SKUs, thousands of companies around the world must establish an electronic, interoperable dialog. There is no shortage of connections to be made. On the production side there are as many as 5,000 connections necessary to network packagers, drug manufacturers, repackagers, and third-party logistics providers assuming each of the 2,000 producers needs on average 2 -3 connections per manufacturer. The largest wholesale distributors connect to as many as 500 drug producers which means for just the “Big Three”, 1,500 connections are needed. The remaining 90+ wholesale distributors are likely to, on average, need to connect to six drug producers, increasing the number of connections by an additional 500. Therefore, an estimated 2,000 connections are necessary for drug producers to connect inbound to distribution. Finally, each point of distribution must connect and communicate with more than 200,000 healthcare providers, which is likely to require an additional 2,000 connections.

Need for standards
As complexity increases and information exchange becomes more important, it is necessary for standards to be formed to ensure that products, processes, and procedures fit together and interoperate — and that there is a “universal language” of sorts to relay this information.

When it is critical for businesses to communicate effectively, standards matter. Standards allow different businesses to act in harmony enabling uniformity, reliability, accuracy, and precision. By adhering to standards, companies and organizations can work together to build products like cars, computers, and cell phones, or securely exchange personal, patient, product, and financial information. Without well-defined requirements and strict adherence to standards, we struggle to establish interoperability and information exchange. To achieve accurate, rapid, robust, reliable connectivity with minimal errors, conformance to accepted standards is essential.

DSCSA application standards
Application standards are necessary to trace uniquely identified medicine containers as they move from initial packaging through the warehouse and then to the point of drug dispensation. The entities and their location involved with each drug transaction from initial introduction into commerce to the point of dispense must be captured, stored in immutable records, and be easily understood.

Fortunately, tracking, capturing, and accessing this data is made possible by the Electronic Product Code Information Services (EPCIS), a GS1 standard which enables trading partners to represent and share information about the physical movement and status of products as they travel throughout the supply chain. It is essentially a common language that knows the details of each transaction (the what, where, when, and why) and facilitates a shared view of physical objects within, and between, enterprises.

Since EPCIS is in use around the world to address a variety of business needs across many industries, application specific standards are necessary to tailor EPCIS to suit a specific purpose. The GS1 Healthcare US working group, made up of 50+ companies representing a cross-section of the industry, published EPCIS application standards governing DSCSA traceability in 2016. Within months, each of the major US wholesalers published EPCIS onboarding guides based on the GS1 DSCSA application standards. Impediments to change, such as re-validating an existing system, are a barrier to standards adoption. However, things are changing; most new deployments are specifying EPCIS 1.2, a prerequisite for DSCSA traceability conformance.

Although the drug manufacturer is responsible for product packaging and drug-transaction data accuracy, it is the drug wholesaler that feels the impact of standards non-conformance. As noted, the wholesalers face the daunting task of having to onboard and receive drug traceability information from hundreds of manufacturers.

“A high-percent of the files we see for the first time have EPCIS conformance issues,” says Jeff Denton, VP of Supply Chain at AmerisourceBergen. “Avoidable issues require a significant amount of human resources to identify, communicate, resolve, and retest. It simply isn’t scalable for wholesalers to troubleshoot the standards conformance issues that conformance testing could address ahead of time.”

‘Almost’ compliant?
One EPCIS solution provider wrote us recently “If we are not currently perfectly compliant with GS1 standards, we are extremely close.”
As Ken Traub, an EPCIS visionary and the inspiration for our conformance tools once remarked: “There is no such thing as ‘almost’ standards compliant; it either is or it is not.”

Recognizing the need to establish unambiguous DSCSA conformance, GS1 established a conformance testing certification program to identify non-conformances and improve DSCSA traceability and interoperability. Requirements were developed for a reliable, scalable, and robust testing and certification service.
Rigorous testing benchmarks were established by the GS1 US working group to ensure common assessments of similarly constructed traceability scenarios. A certification program was launched to certify independent companies, like Gateway Checker, as a Conformance Testing Service.

As a result, opinions and creative interpretations can be supplanted with facts and an unambiguous assessment. Unbiased third parties can objectively test and evaluate conformance to GS1 standards for DSCSA traceability.

Conformance testing ensures implementation consistency among trading partners, aligns data structures, enables common data definitions, and avoids deployment delays.

As a supply integrity consultant assisting with the deployment of serialization systems, I see first-hand the time and effort wasted on bridging the standards conformance gaps. With full DSCSA standards compliance, different solution providers could generate or receive EPCIS messages in a “connect compatible” manner. All required elements would be structured correctly. All necessary content requirements would be mutually understood by the parties. The missing element to assure drug supply interoperability is a testing and certification system that can unambiguously assure message conformance to the DSCSA application standards.

In 2017 I assembled a team of traceability experts and industry practitioners to transform the 35,000 words published in the DSCSA Traceability application standards into a conformance assurance system. Our efforts resulted in a rules-based conformance assessment platform that became known as Gateway Checker. Our conformance assurance service was tested and certified by GS1 as a Conformance Testing Service in 2019. Other conformance testing services are available. [2]

The Gateway Checker conformance testing system relies on hundreds of rules to examine the structure and content of EPCIS messages. Gateway identifies each non-conformance, provides a description of the issue and links to the offended section of the application standard. The system renders an ambiguous response; pass or fail. Passing EPCIS messages can be certified to one of 16 GS1 pharmaceutical traceability scenarios.

With Gateway Checker, proficient analysts can easily self-diagnose compliance gaps within their submitted EPCIS messages. “The Gateway Conformance Testing application provides unparalleled insight into traceability requirements,” said Vasudeva Saladi, Solution Architect, AmerisourceBergen. “It productively identified issues and highlighted what was needed to remedy them.” Late last year, within just a few weeks’ time, AmerisourceBergen became the first company to become Gateway Certified and attain the industry’s first GS1 Trust Mark.

Cost of nonconformance
Not following standards can result in spectacular failures. Who can forget the $125 million Mars orbiter crashing into the planet because an engineering team used English measurement standards instead of the metric system?

DSCSA nonconformance costs are not the type of dramatic failure that panics the industry into change. Rather, it is a steady stream of lost time, excessive resource expense, and unnecessary rework that stretches onboarding projects from weeks to months. Custom-coded connectivity maps resist change and hinder adaptability to new technology and evolving regulatory requirements. Aggregate all the wasted time and effort into a bucket and the industry impact is in the millions of dollars. We know there are significant gaps in drug traceability standards adoption. We have tested more than 100 industry files from different applications and found very few are able to fully conform.

There are substantial benefits from attaining DSCSA Gateway Certification. We have seen first time connections succeed and fully satisfying validation requirements without issue. Imagine the time saved, costs avoided, and confidence established when systems connect and communicate, first time, every time. We are in this together. US drug traceability will advance when manufacturers, contract packagers, repackagers, regulators, and EPCIS solution providers understand that conformance to standards matters! To this end, Gateway Checker is offering a complimentary readiness assessment of an EPCIS file: go to https://gatewaychecker.com/readiness-assessment/ and use the code PharmaComJune20 to begin the process.

References
1. https://oig.hhs.gov/oei/reports/oei-05-17-00460.pdf
2. https://www.gs1us.org/what-we-do/partners/find-gs1-us-solution-partner/find-rx-epcis-conformance-tester

About the Author
Gary LernerGary Lerner, founder of Gateway Checker, is an accomplished architect of supply integrity solutions. An expert in item-level serialization, Gary has developed successful supply chain and channel integrity solutions for nearly 100 leading brands around the world, serving the needs of pharmaceutical, medical device, packaged food, electronics and apparel manufacturers.

The post How to ensure conformance to EPCIS standards in drug traceability appeared first on Pharmaceutical Commerce.

Sensitech upgrades its real-time cold-chain tracking capabilities

The SensiWatch Platform employs IoT data-collection instruments and data-management tools, the better to provide an end-to-end visibility of shipments, including both geo- and condition (temperature, humidity and light) tracking. Internally, SensiWatch uses cloud-based storage (building on its earlier ColdStream data-tracking services) a data warehouse, Application Programming Interfaces (APIs) for integrating with existing customer applications and third-party data sources, multiple levels of reporting and real-time analytics.

According to the company, basic reporting includes Supplier Network Overview, Segment Performance, Supplier and Carrier Compliance. Advanced reporting includes: Estimated Time to Arrival, Dwell Times, Simulated Product Temperature, Lane Risk Analytics, Weather Impact, and Crime Risk. “We’re now talking about good cold chain management, quality risk management, security, transparency, and authenticated chain of custody,” said Henry Ames, GM–Life Sciences. “The temperature map of each load is still critical, but we’ve taken a much more holistic view of supply chain integrity.”

There is an increasingly crowded arena for providing condition and location monitoring for pharma shipments. Historically, unconnected devices would be manually read out at the end of a shipment; now, there are monitoring services providing near real-time tracking from the freight forwarders themselves, from packaging or container providers, from instrument manufacturers like Sensitech, and from third-party telecom firms that seek to connect the devices, the carriers and the intermediary service providers. More competition means more choices for the pharma shipper.

Sensitech Ryan thermostat

The Ryan bimetallic ‘thermostat’, circa 1930, for cold-chain tracking.

Simultaneously with this announcement, the company is taking note of its 30th anniversary and has posted a fascinating look backward on its evolution, as well as the general topic of condition tracking for temperature-sensitive materials. The technology can be traced back to Ryan Instrument Co. (which Sensitech acquired in 2000) and its strip-chart recorder for perishable food shipping. After its 1990 founding, Sensitech was acquired by United Technologies in 2006 and merged into a business unit that included Carrier Corp. In April, Carrier was spun out from UTC.

The post Sensitech upgrades its real-time cold-chain tracking capabilities appeared first on Pharmaceutical Commerce.