ISO 21973 Certification

Setting the Highest Standard for Animal Health Logistics

Applying the most rigorous global standard to every shipment

Cryoport Systems is proud to be the first global supply chain solutions company certified under ISO 21973:2020. While this standard was developed for human medicine, we universally apply its stringent requirements across all shipments, including those for animal health. This proactive approach delivers therapies in optimal condition, mitigating risk and positioning your organization ahead of evolving regulatory frameworks.

  • ISO 21973 is the global benchmark for transporting (human) cells for therapeutic use under controlled conditions
  • Cryoport Systems is the first and only global supply chain solutions company certified under this standard
  • Continuous Monitoring alongside validated equipment and qualification protocols plus complete chain-of-custody integrity protect every shipment

Future-proof your supply chain by adhering to ISO 21973:2020, the highest standard in the industry

  • Purpose of ISO 21973: Introduced in 2020, ISO 21973 provides a unified framework for transporting therapeutic cells under controlled conditions. It sets requirements for environmental control, equipment validation, and communication protocols to provide product viability throughout transit.
  • Cryoport Systems’ Role in Development: We actively participated in the Standards Coordinating Body working group that shaped ISO 21973. Our expertise in biologics logistics informed the standard’s evolution, aligning with our long-standing Chain of Compliance® principles.
  • Why Animal Health Needs this Standard: Advanced biologics and regenerative therapies for animals are becoming as complex as those for humans. Applying ISO 21973 today mitigates risk and positions animal health organizations ahead of regulatory changes.
  • Compliance in Action: Every Cryoport Systems shipment benefits from validated packaging, continuous condition monitoring, and rigorous requalification processes. Our Veri-Clean® decontamination protocol eliminates 99.9999% of external contaminants, ensuring biosecurity for sensitive materials.
  • Future-Proofing Global Supply Chains: ISO 21973 certification supports scalability and operational efficiency. By managing complexity and reducing risk, we enable animal health stakeholders to expand confidently into new markets without compromising quality

Exploring the Impact of ISO 21973 on Animal Health Logistics

Why applying the most stringent human health standard to animal health matters now and for the future

ISO 21973 is the highest global benchmark for safeguarding the integrity of living cells during transport. Originally developed for (human) regenerative medicine, this standard addresses the most critical risks, including things like temperature excursions, contamination, and chain of custody breaches, that can compromise therapeutic efficacy. Cryoport Systems helped shape this standard and is now the first and only global supply chain solutions company certified under ISO 21973. By applying these principles to animal health shipments, we deliver unmatched reliability for biologics, vaccines, and reproductive materials alike, providing biosecurity and product integrity for every stakeholder from pharmaceutical innovators to livestock managers and veterinary care providers.

By partnering with Cryoport Systems, you gain access to a comprehensive supply chain framework that anticipates regulatory evolution and proactively mitigates risk, assuring protection of every shipment. Whether you’re developing next-generation biologics, managing herd health programs, or delivering advanced therapies in clinical settings, our certified processes provide the confidence and reliability you need to succeed.

 

Cryoport Systems doesn’t wait for regulations to catch up. We set the benchmark for safety and reliability in animal health logistics.

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Setting the standard today for the therapies of tomorrow

Your Partner of Choice in the Mission to Protect Animal Health

Animal Pharma

Delivering complex biologics and advanced therapies requires flawless execution. Our ISO 21973-certified processes ensure validated systems, continuous monitoring, and complete traceability to support your journey from development to global commercialization.

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Livestock Management

Biosecurity is critical for herd health and food supply chains. By applying ISO 21973 protocols to every shipment, Cryoport Systems minimizes contamination risks and delivers vaccines and reproductive materials arrive under controlled conditions.

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Veterinary Care

Managing advanced therapies shouldn’t add complexity to your clinic. Our certified processes guarantee that treatments arrive without deviation, enabling timely care and better outcomes for animals while reducing logistical burdens on your staff.

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Advanced logistics, assured protection