What Is ISO 21973 And Why It Matters For Cell And Gene Therapy

Cell and gene therapies require precise handling and transportation to maintain viability and patient safety. ISO 21973 provides a globally recognized framework for managing these challenges, establishing best practices for packaging, temperature control, documentation, and chain-of-custody. By defining clear requirements for logistics providers and manufacturers, this standard reduces variability and risk in the movement of advanced therapies.

Compliance with ISO 21973 is more than a regulatory checkbox—it’s a strategic necessity. Adhering to these guidelines ensures consistency across international supply chains, supports regulatory alignment, and builds trust with stakeholders. It also helps organizations mitigate costly errors, protect product integrity, and streamline processes as therapies scale from clinical trials to commercial distribution.

For companies operating in the CGT space, understanding and implementing ISO 21973 is essential to delivering therapies safely and efficiently. Explore how this standard shapes the future of CGT logistics and why it matters for your operations.