Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. But the fragility of regenerative medicine therapies – and the need to more effectively manage risk– means that a fourth chain will soon be a regulatory requirement: the Chain of Compliance®. Enhanced traceability within the temperature-controlled and cold chain logistics distribution will soon be subjected to additional regulatory requirements due to the fragile aspect of the drug product and the disproportionate risk of improper cold chain management on the viability of the therapies.
As anticipated, the International Organization for Standardization (ISO) has recently issued its eagerly awaited guidance on the transportation of cell for therapeutic use (ISO 21973). The ISO document is meant to provide general requirements and points to consider for transportation service providers, clients and senders to ensure cell quality, safety and efficacy during the transportation process. Key elements covered in the requirement include traceability, equipment performance, segregation of human- and animal-derived products, validation and qualification activities.
Traceability can be accomplished using Chain of Compliance® processes which provide visibility and storage of critical data. Chain of Compliance® provides full traceability of the equipment and processes used in managing the environmental control of the commodity. This includes equipment performance, commodity history, equipment requalification, calibration history and correlation of in-field events.
Robust data management is the key to mitigating risk and better understanding variability of an uncontrolled system. The ability to collect, interpret, and leverage all of this data provides a more intelligent supply chain. Rather than trying to determine what has gone wrong after multiple failures, it becomes possible to take a proactive approach. Perhaps most importantly, robust near real-time data can alert you to problems before they become costly failures. Having the ability to assess risk and intervene when unexpected problems arise in transit has the power to save time, money, and even lives.
Read our White Paper to learn about taking a proactive approach to ensure compliance standards.
A Leap Forward in Standardizing the Regenerative Medicine Supply Chain – What the New ISO 21973 Guidance Means for Cell and Gene Therapy Developers
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