What is ISO 21973 and Why It Matters for Cell and Gene Therapy
Cell and gene therapies (CGTs) are transforming medicine, but the complexity of these treatments introduces new challenges for supply chain management. Every shipment represents a therapy that could change or save a life, which is a level of responsibility that demands precision and transparency, as well as standards that leave absolutely no room for error. ISO 21973:2020 was created to meet that need.
Understanding ISO 21973
ISO 21973 is the international standard for the transportation of human cells intended for therapeutic use. Published in 2020 by the International Organization for Standardization (ISO), it provides a unified framework for managing all aspects associated with handling and transporting these sensitive materials. From environmental controls to equipment reliability (and even communication protocols), the standard establishes best practices to maintain product integrity during transit. It also addresses risks that can compromise the viability of the therapy, including temperature excursions, contamination risks, and breaches in the chain of custody.
Before ISO 21973, the CGT industry lacked a globally recognized benchmark for these processes. Each organization relied on its own interpretation of best practices, which created inconsistencies and increased risk. The introduction of ISO 21973 changed that by establishing clear requirements around verification and validation throughout the entire transportation process.
Why This Standard Exists
The development of the ISO 21973 standard was driven by the unique demands of regenerative medicine. Unlike traditional pharmaceuticals, living cells are highly sensitive to environmental conditions. Even minor deviations in temperature or handling can render a therapy ineffective, and for patients who are waiting on a life-changing treatment, that risk is unacceptable. For autologous cell therapies addressing oncology applications, this is especially important as there is often only one chance to manufacture and deliver the personalized medicine, and any issues that arise could eliminate a patient’s only chance to access the treatment.
This standard was designed to minimize risk as much as possible by requiring documented processes, validated equipment, continuous oversight, and other risk-mitigating measures, while emphasizing communication between all parties involved in the supply chain to ensure expectations are clear and responsibilities are well-defined. This level of rigor supports not only product integrity but also patient safety.
Implications for CGT Developers
For organizations developing cell and gene therapies, ISO 21973 is the gold standard for operational excellence. Adhering to this standard reduces variability and strengthens confidence in every shipment by confirming that the therapy remained safely in spec throughout the entire transit journey, with documented confirmation and audit-ready detail that archives the full condition and equipment history. ISO 21973 compliance positions companies to meet (and/or exceed) regulatory expectations as global authorities increasingly look to this standard when evaluating compliance.
The benefits of ISO 21973 adherence extend across all phases of development. In pre-clinical work, for example, these principles help establish reliable processes that scale as programs advance. During clinical trials, this level of compliance provides assurance that therapies reach enrolled patients without compromise. At commercial scale, ISO 21973 compliance supports global distribution strategies by creating consistency across regions and partners.
Cryoport Systems and ISO 21973
Cryoport Systems played an active role in shaping the ISO 21973:2020 standard through participation in the Standards Coordinating Body working group. Our experience in managing complex biologics informed the development of requirements that reflect real-world challenges and conditions. Today, we are the first and only global supply chain solutions company certified under ISO 21973.
Certification validates what has long been part of our approach, integrating rigorous process control, continuous monitoring, and complete traceability through our Chain of Compliance® framework. It demonstrates our commitment to setting the highest benchmarks for safety and reliability in CGT logistics.
Industry Standardization
ISO 21973 represents a critical quality framework that helps to harmonize an industry that’s expanding rapidly. As more cell and gene therapies transition from early development to commercialization, the need for consistent standards will only increase. Organizations that proactively adopt ISO 21973 are not only meeting today’s expectations but also preparing for the regulatory considerations of tomorrow.
Cryoport Systems is proud to lead the way in implementing the industry’s most stringent compliance and quality standards. By aligning our processes with ISO 21973 and achieving certification, we provide CGT developers with a supply chain solution intentionally built for integrity and scalability as we work to Enable the Outcome™ for our clients and the patients they serve.
