Cryoport Systems Sets New Benchmark for the Global Regenerative Medicine Supply Chain
First Global Supply Chain Solutions Company to Achieve ISO 21973 Certification, Ensuring Highest Transport Safety, Traceability, and Integrity Standards for Cell and Gene Therapies
Cryoport Systems has achieved a significant milestone by becoming the first global supply chain company worldwide to secure ISO 21973:2020 certification from the DNV Business Assurance. This certification marks a pivotal advancement in our mission to set the highest benchmarks for safety, traceability, and product integrity in the cell and gene therapy sector and across the life sciences.
Transporting therapeutic cells for regenerative medicine demands flawless execution at every stage, as even minor deviations can compromise patient outcomes. ISO 21973, introduced in 2020, offers a globally unified framework of rigorous guidelines that address environmental controls, equipment reliability, and logistics to ensure the safe and effective delivery of living cells. By minimizing risks such as temperature excursions, contamination, and chain-of-custody breaches, the standard supports the viability and integrity of these sensitive therapies. Cryoport Systems played a key role in shaping ISO 21973 through its participation in the Standards Coordinating Body working group, helping to establish a new benchmark for supply chain excellence in the life sciences.
Understanding ISO 21973: A Critical Standard for Regenerative Medicine
The ISO 21973 standard addresses the unique challenges of handling living cells, where precise conditions are essential to preserve viability and efficacy. Even small deviations like temperature fluctuations or breaches in the chain of custody can impact patient outcomes in regenerative medicine. The standard includes requirements for developing transportation plans, including verification, validation, and clear communication between clients and service providers. By minimizing risks like contamination and tracking inconsistencies, ISO 21973 ensures that therapies arrive in optimal condition to support reliability across the supply chain and (ultimately) better outcomes for patients.
The Development Journey of ISO 219731
The origins of ISO 21973 trace back to 2014, when the ISO/TC 276 Japanese Mirror Committee began work on definitions and general requirements for cell transportation. This early effort laid the groundwork for addressing gaps in the regenerative medicine supply chain. In 2016, the Standards Coordinating Body (SCB) joined the initiative, forming a working group in October of that year with more than 20 experts from government institutions, membership organizations, and industry (including Cryoport Systems). The group focused on identifying needs related to IT infrastructure, chain-of-custody systems, centralized logistics, shipment tracking, and monitoring protocols.
Collaboration between U.S. and Japanese teams was central to the process. By June 2018, initial drafts were submitted for discussion at an ISO/TC 276 meeting. The Japanese Mirror Committee handled editing, incorporating feedback through multiple rounds of revisions to ensure clarity and broad stakeholder input. This iterative approach combined two documentary standards into one comprehensive framework. The standard was ultimately finalized and published in June 2020 as ISO 21973: General requirements for transportation of cells for therapeutic use. Developed under ISO/TC 276, it represents a global consensus on best practices for maintaining product safety and efficacy during transport.
Cryoport Systems’ Key Contributions and Leadership
Cryoport Systems played an active role in shaping ISO 21973 through its participation in the SCB working group. Our expertise in logistics for cell therapy products informed the standard’s development, aligning with our long-standing Chain of Compliance® framework, which incorporated these principles even before formal certification was available.
“With the first and only ISO 21973 certification in the market, Cryoport Systems further solidifies our position as a pioneer in the life sciences industry” said Jerrell Shelton, CEO of Cryoport. “We helped shape this standard. We have long adhered to this standard even before certification was possible. Now, we’re proud lead the industry in successful certification of these rigorous requirements.”
Broader Applications and Lasting Impact
Beyond cell and gene therapies, Cryoport Systems extends these standards to reproductive medicine and animal health, offering consistent reliability across multiple life sciences applications. The certification confirms our ability to mitigate key risks, such as temperature excursions and contamination, to ensure your therapies maintain their integrity throughout the journey. This not only enhances patient safety but also supports the scalability of regenerative medicine by providing a trusted framework for global supply chains.
For more details on Cryoport Systems’ ISO 21973 compliance and our role in advancing the regenerative medicine supply chain, download our whitepaper on the standard.
