ISO 21973 Certification Sets a New Standard for Animal Health Supply Chains
Cryoport Systems has achieved a milestone that redefines excellence in life science logistics by receiving ISO 21973:2020 certification. While this international standard was designed for the transportation of human cells for therapeutic use, over the past several years we’ve taken the bold step of applying its stringent requirements across all shipments and processes, including those in animal health. This proactive approach ensures that animal health stakeholders, from pharmaceutical innovators to livestock managers and veterinary care professionals, benefit from the most advanced compliance framework available today in full alignment with tomorrow’s regulatory landscape.
What is ISO 21973?
ISO 21973 is the global benchmark for transporting living cells that are intended for therapeutic use (either as starting materials or final drug product) by adhering to stringent conditions that preserve cellular viability and integrity. Introduced in 2020, the standard provides a unified framework for managing critical aspects of the temperature-controlled supply chain like environmental controls, equipment history and reliability, logistics, and communication protocols throughout the transportation process. It addresses risks like temperature excursions and contamination, as well as chain-of-custody breaches. Any one of these issues could compromise therapeutic efficacy and, therefore, patient outcomes.
Although ISO 21973 was developed for human regenerative medicine, its principles are universally relevant to any supply chain handling sensitive biological materials. By adopting these requirements for animal health shipments, Cryoport Systems delivers therapies in optimal condition, safeguarding both product integrity and end-user confidence. Quality measures that are standard operating procedures for Cryoport Systems in full compliance with ISO 21973 include:
- Use of custom-engineered shipping systems that have been designed specifically for the safe transport of temperature-sensitive biological materials
- Continuous monitoring with integrated condition monitoring to track geolocation, internal and external temperature, tilt, shock, and other critical parameters of every shipment throughout transit
- Complete Chain of Compliance® from end-to-end, including historic equipment history and shipment data preserved in our Cryoportal® logistics management system for 10+ years for audit-ready track and trace
- Robust requalification processes of every shipping system before every use to ensure performance, confirming that the shipping system is free from physical defects and maintains hold times
- Validated Veri-Clean® decontamination that eliminates 99.9999% of external contaminants like bacteria, viruses, and fungi applied to every shipping system before every use to ensure biosecurity
Why Apply Human Health Standards to Animal Health?
The animal health industry is evolving rapidly, with advanced biologics, regenerative therapies, and next-generation vaccines for livestock and companion animals becoming increasingly complex. This means animal health-focused organizations are naturally facing many of the same challenges seen in human medicine. Still, regulatory frameworks for animal health logistics have not yet fully matured, although this development is accelerating. This gap, however, creates risk for manufacturers and providers who must maintain product integrity without clear global standards.
Cryoport System bridges that gap by applying ISO 21973 requirements to animal health shipments today, well in advance of the changing regulatory landscape. This means animal pharmaceutical companies, livestock managers and breeders, and veterinary care providers can operate with confidence, knowing their supply chain meets the most stringent standards, even before regulations demand it.
ISO 21973 compliance delivers tangible advantages for animal pharmaceutical companies by reducing risk while strengthening supply chain integrity. Every shipment follows rigorous, validated processes designed to maintain therapeutic efficacy from production through administration, with scalable support that begins in early development, grows with you through clinical trials, and supports eventual global commercialization. This proactive approach not only safeguards product quality but also positions manufacturers ahead of regulatory developments, signaling leadership in quality assurance and operational excellence.
Livestock management organizations also stand to gain significantly from these standards. Biosecurity is a critical concern, and compromised vaccines, biologics, or reproductive materials can have devastating consequences for herd health and expansion as well as food supply chains. By applying ISO 21973 protocols to all shipments, Cryoport Systems minimizes contamination risks and delivers sensitive biologics under controlled conditions. This level of reliability supports herd health and breeding programs and protects the continuity of agricultural operations.
In a similar way, veterinary care providers benefit from the assurance that complex therapies will arrive in optimal condition without requiring additional handling or oversight from internal point-of-care teams who are already stretched thin. Continuous monitoring and validated equipment eliminate uncertainty, enabling clinics to focus on timely treatment rather than logistics. This reliability translates into better outcomes for animals and greater confidence for veterinary teams managing advanced therapies.
Leading Today, Preparing for Tomorrow
At Cryoport Systems, our leadership in ISO 21973 certification goes beyond compliance. Our focus is on foresight and the future of the industry. We played an active role in shaping this standard through participation in the Standards Coordinating Body working group. We integrated its principles into our proprietary Chain of Compliance framework long before certification was available. Now, as the first and only global supply chain solutions company certified under ISO 21973, we offer animal health stakeholders a level of assurance unmatched in the industry.
Maintaining compliance demands a culture of excellence supported by rigorous processes. Every Cryoport Systems shipment benefits from validated equipment and packaging designed to assure protection of the sensitive biologics contained within. Our logistics platform provides continuous monitoring of temperature, location, and chain of custody, ensuring transparency and accountability at every stage. And standardized workflows and documented communication protocols further reinforce reliability, while ongoing training and auditing keep our teams aligned with best practices.
The challenges facing animal health logistics are not static. As therapies become more advanced and global distribution networks expand, the risks associated with transportation will only increase. Cryoport Systems addresses these challenges head-on by delivering solutions that solve pain points both now and in the future.
Risk mitigation is central to our approach. By minimizing temperature excursions, contamination, and tracking and data inconsistencies, we reduce product losses and protect therapeutic integrity. Our adherence to and certification in ISO 21973 supports regulatory readiness, enabling animal health organizations to stay ahead of compliance requirements as industry standards evolve. By managing the complexity of logistics for biologics and advanced therapies, we optimize operational efficiency and free stakeholders to focus on innovation and care delivery. And our global infrastructure ensures scalability, supporting expansion into new markets without compromising quality.
Cryoport Systems is proud to lead the way by applying ISO 21973 standards to animal health. This achievement reflects our commitment to setting the highest benchmarks for safety and traceability across all life science sectors. For animal health organizations, partnering with Cryoport Systems means more than meeting today’s expectations; it means you’re actively future-proofing your supply chain to meet tomorrow’s challenges with confidence.
