Cryoport Achieves ISO 21973 Certification, Setting New Standards for Supply Chain in Regenerative Medicine

Cryoport Sets New Benchmark with ISO 21973 Certification

In a groundbreaking move for the regenerative medicine sector, Cryoport, Inc. (NASDAQ: CYRX) has announced its achievement of the ISO 21973:2020 certification, a significant milestone that underscores the company’s commitment to safety, traceability, and integrity in the logistics of therapeutic cell transportation. As a recognized leader in temperature-controlled supply chain solutions for life sciences, Cryoport’s new certification solidifies its position at the forefront of the rapidly evolving field of cell and gene therapy.

The ISO 21973 standard, introduced in 2020, establishes comprehensive guidelines for managing environmental control and logistics in the transport of human cells meant for therapeutic use. Cryoport Systems has been actively involved in the development of this standard, working within a coordinated group that aimed to ensure adequate safety precautions for the integrity of living cells in transit. Managing these conditions is crucial as any deviation in temperature or environment can jeopardize the viability of potentially life-saving therapies.

Jerrell Shelton, the CEO and Chairman of Cryoport, expressed pride in this accomplishment, stating, "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." He emphasized the importance of pre-established standards that define rigorous requirements for maintaining the efficacy of regenerative medicine therapies.

This certification not only reflects Cryoport's commitment to its proprietary Chain of Compliance® system but also enhances its credibility and reliability as a supply chain provider in the life sciences sector. In recognition of their robust supply chain platform, Cryoport Systems has also won the 2025 CPHI Award for Supply Chain Excellence, demonstrating the industry’s acknowledgment of their integrated solutions tailored to meet the needs of the regenerative medicine market.

While the ISO 21973 standard is specifically designed for regenerative medicine, the rigorous protocols set forth are being applied broadly across various life sciences sectors, including reproductive medicine and animal health. This approach allows Cryoport to deliver consistent quality and reliability to all clients while minimizing risks associated with temperature excursions, contamination, and chain of custody breaches.

In supporting biopharmaceutical companies, contract research organizations (CROs), and contract manufacturers (CDMOs), Cryoport’s integrated supply chain platform encompasses a wide array of services and products focused on minimizing risks and maximizing reliability. Key offerings include the Cryoportal® Logistics Management Platform, advanced temperature-controlled packaging systems, biologistics, and cryogenic solutions—all designed to enhance the efficiency of temperature-sensitive supply chains.

Cryoport's efforts to innovate and adhere to regulatory standards are paving the way for advancements in the therapeutic field, where precision and safety are not merely regulatory requirements but vital to patient outcomes. Headquartered in Nashville, Tennessee, the company has established a robust presence globally, with operations extending throughout the Americas, EMEA, and APAC, all while remaining at the cutting edge of supply chain solutions for regenerative medicine.

For more details on their ISO 21973 certification and its significant implications for regenerative medicine supply chains, interested parties can visit Cryoport's official website or download their informative white paper on the standard. As Cryoport continues to lead the way in next-generation supply chain solutions, it showcases its dedication to enabling the future of medicine.

In conclusion, Cryoport's pioneering steps to align with international standards reflect not just a business acuity but a profound responsibility towards improving therapeutic delivery systems, ensuring that life-saving treatments reach those in need with utmost safety and efficacy. The achievement of ISO 21973 certification not only adds a prestigious feather to Cryoport's cap but also serves as a benchmark for the entire regenerative medicine supply chain industry.