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With cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.
Cellular therapies-a category that includes regenerative medicine and immunotherapy-offer the potential to improve the practice of medicine and to fill unmet needs for patients with few or no treatment options. However, your supply chain team may have less experience with these products, which require new technologies, capabilities and resources that may not be available in-house. Moreover, distribution can be challenging, as many of these therapies must be shipped and stored at cryogenic temperatures.
In addition to strict temperature guidelines, these cellular-based therapies have multi-step supply chains that present a new layer of complexity to scheduling and track and trace. Whereas traditional pharmaceuticals have a linear supply chain model that is less time sensitive, many cell therapies have a circular supply chain. For example, the manufacture of an autologous therapy requires obtaining cell materials from a patient, sending the materials to processing and manufacturing facilities, and then shipping the finished product back to the same site for patient administration, leaving no room for error in tracking or traceability.
Biopharmaceuticals are incredibly sensitive to the slightest changes in temperature, pressure, humidity or other conditions. For cell therapies, a very specialized approach that involves both temperature control and scheduling is vital to maintain the integrity of the product. The distribution of cell therapies not only requires constant temperature control but is also extremely time-sensitive. As soon as a sample is taken from a patient, cell loss and degradation begin almost immediately, leaving perhaps only 36-48 hours to get the harvested biomaterials to the manufacturer. Any variation in temperature, or interruption in the supply chain, can impact clinical trial results by compromising data integrity and potentially the product’s efficacy and safety.
Many of these programs are global with a centralized manufacturing capacity. Consequently, cold chain transport not only requires a sophisticated understanding of innovative shipping technologies, but continuous monitoring, recording and documentation of the condition of the biologic material
throughout the journey-and, if necessary, proactive intervention to remediate issues that arise during shipment. The distribution process also requires reverse-logistics planning, as the packaging must be returned for cleaning, revalidation and recharging.
The complexities surrounding the manufacture and distribution of cell therapies have spawned the development of liquid nitrogen dry vapor shippers and other packaging innovations that enable shipment and storage at stable cryogenic temperatures. They have also sped the adoption of sophisticated logistics systems that provide data collection and active/live monitoring capabilities.
It should come as no surprise that agencies such as the International Society for Biological and Environmental Repositories, the World Health Organization, the FDA, the U.S. Pharmacopeial Convention, the International Air Transport Association and the International Organization for Standardization have issued or are reviewing guidelines for the storage and distribution of biological materials. Such regulatory scrutiny ups the ante for adoption of logistics management technologies that provide complete chain-of-condition and chain-of-custody tracking.
When fully integrated with clinical software, logistics management systems can coordinate smoothly with patient site visits. These systems can also help optimize workflows, ensuring the seamless transit of biological materials from patient to manufacturer and back to the patient. Even if your clinical trial is in the protocol-planning stage, it’s not too early to incorporate cold chain logistics into the planning process.
Tamie Joeckel is Senior Vice President of Client Services and Consulting, Cryoport