How to Ensure Full Compliance Throughout Every Step of the Journey

In June 2020, the ISO/TC 276 Biotechnology Technical Committee defined a new standard for the transportation of cells for therapeutic use. The cell and gene therapy industry requires end-to-end precision and traceability — everything from chain of custody to chain of condition and chain of identity. ISO 21973:20202 extends the chain by focusing on the complete traceability of the equipment, processes, and logistics used in managing the environmental control of the therapy while it is in transit.

This extended “Chain of Compliance®” provides complete traceability, control, and oversight of the entire transportation process, which is crucial for viable scalability.