The Regenerative Medicine Supply Chain: Anticipate New Compliance Standards Now Or Risk Falling Behind

The advent of regenerative medicine is among the most significant events in modern medicine. The first large-scale launches of these therapies took place in 2017,1 and a large range of cell therapies, therapeutic tissue engineering products, human cell and tissue products, and therapies or products that combine some of these techniques are currently under development around the world.

• While showing significant promise, regenerative medicine materials are inherently fragile and more at risk than other products during the supply chain process. Cross-contamination, orientation and handling problems, and equipment failure all have potential to damage irreplaceable materials.
• To avoid this, traceability, along with efficient data management, is imperative and can be addressed using Chain of Compliance™ processes. This efficiently traces the equipment and processes used in managing the environmental control of the product.
• While few industry-wide standards currently exist, the industry can expect new regulations in nine areas, which are outlined in this white paper.
• Ensuring compliance, however, can be a lengthy endeavor. This white paper outlines seven steps that companies should take now to ensure future compliance.
• Companies who fail to anticipate compliance standards now will fall behind.