As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably.
In January 2019, former commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb, M.D. issued a statement regarding the impending cell and gene therapy boom, which began in earnest this year. Citing an increase in the amount of cell and gene therapy-based investigational drug approval (IND) applications landing at the agency, it is clear that this trend will only continue to grow.1 By 2020, the FDA anticipates reviewing more than 200 IND approvals annually, which will add considerably to the 800 active cell-based or directly administered gene therapy INDs currently on file. Based on these figures, 10–20 cell and gene therapies are anticipated to be approved every year.1
Cell and gene therapies are unique in that they often address conditions for which no other treatment options exist, which makes their approval even more crucial. In the statement, the FDA pledged their commitment to advancing the field of cell and gene therapy, outlining the steps needed to do so.1 Following the agency’s example, supply chain providers who serve as the logistical backbone of the industry must evolve to ensure that these therapies — which are developed using the most advanced technology the industry has to offer — are fully supported. For some logistics providers, that might mean a total redesign of services to stay relevant as a cell and gene therapy distributor.
Yourway Biopharma Services has the infrastructure needed to service the industry no matter how complex a drug may be. We have a robust and advanced temperature-controlled supply chain offering, as well as integrated transportation and packaging services, which are designed with the patient in mind. Our services address the major concerns surrounding cell and gene therapy logistics, including how extremely sensitive materials should be stored and transported.
A Vein-to-Vein Supply Chain
The cell and gene therapy supply chain is inherently patient-centric, as this is the first time that patients themselves are a key part of the supply chain. With cell and gene therapy, patients either donate their cells or receive a live therapy, creating a supply chain that has been dubbed “vein-to-vein.”2 In order to ameliorate this key step of patient inclusion, platforms that create a connection between the therapy and the patient must be implemented — this will not only increase traceability and help ease how outcomes are monitored, but will also ensure that no errors are made, in terms of administration or other factors, that could have life-threatening repercussions.3
Another key concern regarding the shipment and distribution of cell and gene therapies is temperature control. Cell and gene therapies have a narrow window of viability and need to be shipped immediately to preserve the time that the cell is active. That the shipping time is constrained by the time that the cells are viable adds pressure to logistics providers. Supply chain companies that possess larger networks and have access to more depots are at an obvious advantage.
The shorter the shelf life of the cell therapy, the more intense the logistical challenges. This is especially true on an international level, where issues with customs and specialized regulatory requirements come into play. As more cell and gene therapies make it past the approval phase, there is a risk that the infrastructure needed to handle these therapies will not be fully in place, which would create a major bottleneck and put patients (and the drugs) at risk.4 Considering the cost of cell and gene therapies, nondelivery or spoiled delivery would have detrimental consequences.
Cell and gene therapies are typically stored at cryogenic temperatures below –60 to –150 °C. This temperature allows the cells to be kept potent and ensures an optimal cell count. Designated shipping containers that can support these extremely cold temperatures must be used to protect the cell or gene therapy. Two common types of containers include a dry ice shipper and dry nitrogen vapor shippers. The shipment should include real-time temperature monitoring to ensure that nothing affects the shipment after it has been deployed.2
A temperature-monitored tracking device should be embedded within the shipment and create an alert when various issues occur, for instance, if dry ice should be refilled or when liquid nitrogen needs to be recharged, as well as when the shipment has reached landmark intervals along the journey. The shipment must also be packed durably so that the therapy remains unaffected by extreme physical conditions. Improper packaging or labeling of a shipment could result in shipment errors or a compromised sample. Quality control is also essential in supply chain logistics. Shipments must be cross-checked comprehensively to ensure that there are no leaks or other issues, which could subject the sender to an audit by the FDA or other regulatory agencies.2
At Yourway Biopharma Services, we emphasize diligence to ensure that our shipments are compliant. We utilize state-of-the-art technology and are experts in temperature-controlled logistics, having invested in the tools that are needed to keep up with rapid breakthroughs in medicine as they occur. We are dedicated to preventing bottlenecks in the industry and have a network comprising 21 global depots. Through this network, we are able to manage international shipments effectively and efficiently.
The Yourway Difference
We offer fully integrated services for cell and gene therapy distribution that go above and beyond. We provide primary and secondary clinical packaging, temperature-controlled logistics and storage services, all of which are available across the world.
Yourway is the only truly integrated premium courier and clinical packager that has warehousing and distribution support and expertise in temperature-controlled solutions. We offer unused product return services and assistance with logistics project management. Our experts aid in the sourcing of comparator drugs and other supplies, strategize the most opportune delivery route for trials globally, handle documentation support and give advice on regulations country by country.
Yourway employs a dedicated staff of experienced logistics providers who solve supply chain challenges routinely. With decades of experience, our people have an intimate understanding of what is required for advanced therapies to ship out successfully, including expertise in all aspects of temperature sensitivity and the temperature-controlled chain. We have top-of-the-line technology installed to ensure that all shipments are delivered on time or sooner and according to all specifications. We can guarantee this speed of delivery because we customize our transportation solutions to fit the needs of each client and ship on an individual basis to make sure that we are providing the highest level of service.
We take advantage of our pre-clearance capabilities at customs agencies worldwide so that time-sensitive shipments are not delayed by international borders. Our deliveries are expedited proactively so that our agents can bring shipments to their destination without issue. We have no size or weight restrictions, so customers can rely on us regardless of what is being shipped out, or where. Partnering with Yourway is a way to shorten turnaround times and make sure that cell and gene and other advanced therapies reach patients as soon as they are supposed to, wherever the patients are.
References
- https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics
- https://www.cellandgene.com/doc/critical-considerations-for-packaging-and-delivery-of-gene-therapy-products-0001
- https://www.cellandgene.com/doc/sneak-peek-the-unique-challenges-of-cell-and-gene-supply-chains-0001
- https://www.pharmalogisticsiq.com/logistics/articles/channeling-cell-and-gene-therapies-through-the
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