Are You Complying With ISO 21973? General Requirements For Transportation Of Cells For Therapeutic Use

By 2025, the Food and Drug Administration (FDA) predicts the industry could have as many as 20 new commercial regenerative medicine therapies coming to market each year, requiring safe and effective delivery of multiple-thousands of individual doses.

If the FDA is accurate in its predictions, the regenerative medicine industry is on the cusp of a period of significant growth and rapid innovation. This growth will place unique pressure on the regenerative medicine supply chain to standardize processes and become far more agile while continuing to maintain operational excellence in a zero-failure environment.

However, the ability to deliver on this promise depends entirely on the industry’s ability to deliver these inherently fragile therapies to patients at speed and scale with absolute consistency. As the cell and gene therapy supply chain continues to mature, the inherent lack of standardization threatens to increase the risks and costs of handling these unique therapies.

In June 2020, the ISO/TC 276 Biotechnology Technical Committee defined a new standard for the transportation of cells for therapeutic use: ISO 21973.

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 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 and is crucial for viable scalability.

This white paper helps explain the new requirements of ISO 21973, why it matters, and what steps developers should take to drive compliance.