Next-generation risk mitigation in the temperature-controlled supply chain for advanced therapies with ISO 21973 compliance

The rapid growth of the cell and gene therapy market, projected to reach nearly US$37 billion by 2028, has highlighted the critical need for scalable, reliable logistics solutions to address the complex challenges of transporting temperature-sensitive biologics. This article evaluates the implementation of risk mitigation strategies within the cell and gene therapy supply chain, focusing on compliance with ISO 21973, a standard that provides comprehensive guidelines for the safe transportation of therapeutic cells. Cryoport Systems’ innovations, including the Veri-Clean® validated cleaning protocol and the Chain of Compliance® traceability framework, are examined for their role in safeguarding therapy integrity. Advanced tools like the Smartpak II® monitoring system and the Cryoportal® logistics management system are also discussed for their contributions to near real-time tracking, risk mitigation, and regulatory adherence. Together, these strategies demonstrate how next-generation technologies ensure the quality, safety, and efficacy of cell and gene therapies throughout their supply chain journey, ultimately supporting the commercialization and scaling of advanced therapies.

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