ISO 21973: How To Ensure Full Compliance Throughout Every Step Of The Journey

The field of regenerative medicine is on the verge of significant growth, moving from clinical trials to widespread commercialization. According to MIT NEWDIGS projections, the next decade could see a substantial increase in product approvals and revenues, highlighting the critical need for robust supply chain solutions. Central to this progress is ISO 21973:2020, a crucial standard that establishes best practices for transporting cell and gene therapies.

ISO 21973:2020 is designed to ensure precise and traceable transportation of these therapies through a comprehensive "Chain of Compliance®" framework. This framework not only addresses the logistical challenges of transporting delicate therapies but also minimizes risks associated with temperature fluctuations and handling procedures. With patient outcomes depending on flawless execution, adherence to ISO 21973 is set to redefine industry standards and safeguard product integrity from manufacture to delivery.

In this white paper, we explore the significance of ISO 21973 in a growing market, emphasizing its crucial role in promoting operational excellence and ensuring the safe, reliable delivery of life-saving therapies worldwide. We will also discuss how Cryoport Systems integrates ISO 21973 to support the future of regenerative medicine.