A Leap Forward In Standardizing The Regenerative Medicine Supply Chain

As cell and gene therapies are rapidly moving beyond clinical trials and into commercial markets, the safe and effective delivery of these life-saving treatments needs to be a priority for advanced therapy developers. Can the same supply chain solutions, processes, and systems used during the clinical trial phases handle the increased volume of a commercial therapy on a global basis?

The International Organization of Standardization (ISO) created ISO 21973:2020, titled “General Requirements for Transportation of Cells for Therapeutic Use.” This first-of-its-kind standard is a significant step forward in ensuring that these irreplaceable therapies are always transported consistently, with an emphasis on compliance, validation, decontamination, traceability, and quality management.

Explore which questions to ask your transportation solution provider.