Cryoport Systems, a subsidiary of Cryoport Inc., has received certification under ISO 21973:2020, the international standard governing the transportation of human cells intended for therapeutic use. The certification, issued by the International Organization for Standardization (ISO), highlights the company’s adherence to rigorous safety and traceability protocols within the cell and gene therapy supply chain.

Cryoport Systems was actively involved in the development of the ISO 21973 standard through its participation in the Standards Coordinating Body working group. The standard, introduced in 2020, outlines detailed requirements for environmental control, equipment, logistics, and data management in the transport of living therapeutic cells—where deviations can compromise treatment efficacy.

“Living cells require precise conditions to remain effective,” the company stated. “Therefore, monitoring those specific conditions and ensuring the shipping environment has been maintained is crucial for the viability of regenerative medicine therapies and patient outcomes.” The ISO framework aims to mitigate risks such as temperature excursions, contamination, and breaches in chain of custody.

“With the first and only ISO 21973 certification in the global supply chain solutions market, this achievement further solidifies our position as a pioneer in the life sciences industry,” said Jerrell Shelton, Chairman and CEO of Cryoport. “Having helped develop this industry standard with the ISO, we have long adhered to it with our proprietary Chain of Compliance®. Now, we’re proud to lead the industry in our successful certification of these rigorous requirements. This comes on the heels of winning the 2025 CPHI Award for Supply Chain Excellence for Cryoport Systems’ integrated Supply Chain Platform and is yet another example of Cryoport’s leadership in the regenerative medicine industry, providing novel supply chain solutions to better serve patients.”

While ISO 21973 is tailored to regenerative medicine, Cryoport Systems applies its protocols across other life sciences sectors, including reproductive medicine and animal health.