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, Inc. (NASDAQ: CYRX) ("Cryoport" or "the Company"), a global leader in temperature-controlled supply chain solutions for the life sciences, announced that Cryoport Systems, a Cryoport company, has successfully achieved certification under ISO 21973:2020, the international standard for transportation of human cells for therapeutic use published by the International Organization for Standardization (ISO). This milestone underscores Cryoport Systems' commitment to safety and traceability within supply chain management of the rapidly expanding cell and gene therapy industry.

First introduced in 2020, Cryoport Systems participated in the Standards Coordinating Body working group that developed the ISO 21973 requirements. The final ISO 21973 standard provides comprehensive guidelines for managing the environmental control, equipment, processes, logistics, and information involved in transporting therapeutic cells, where any deviation could mean the loss of a life-changing or life-saving treatment. Living cells require precise conditions to remain effective. 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 21973 requirements minimize the risks associated with temperature excursions, contamination, and chain of custody breaches.

Jerrell Shelton, Chairman & CEO of Cryoport, stated, "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. 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 the ISO 21973 standard is specifically tailored to the unique demands of regenerative medicine supply chain, Cryoport Systems applies these same standards across the life sciences spectrum, including its reproductive medicine and animal health markets.