Preparing Animal Health Logistics for a More Regulated Future
Bringing an advanced animal health therapy to market today demands the same operational discipline once reserved for human biopharma. Yet animal health developers are still operating in an environment that lacks the robust logistics standards that govern human therapeutic transport. As programs expand across sites and geographies, the lack of shared and consistent handling expectations creates variability that becomes one of the biggest operational barriers to scale.
ISO 21973 directly addresses these gaps with a structured framework for managing, documenting, and protecting temperature-sensitive materials throughout transport. Developed with insight from Cryoport Systems’ subject matter experts, many of its principles reflect practices Cryoport Systems had already implemented through our Chain of Compliance® framework. This alignment helps animal health therapy developers establish regulatory excellence ahead of current requirements.
Animal Health Regulations Increasingly Mirror Human Health Expectations
The animal health industry is advancing in parallel to the human biopharma industry. Each faces similar logistics challenges when developing advanced therapies to address hard-to-treat diseases. But despite these similarities, the regulatory landscape for animal health supply chains hasn’t kept pace.
The responsibility for establishing best handling practices for animal health typically falls to individual teams. While building transport procedures is manageable at a single site, consistency erodes as programs expand to additional facilities and regions. Teams that are already stretched thin must, out of necessity, now coordinate across differing SOPs, biosecurity expectations, and documentation systems. The more complex these operations become, the higher the chance that inconsistencies will go undetected. Risk is added at every turn, including the risk that undocumented environmental shifts could hide a warming event during transport that compromises the integrity of the materials, or the risk that there are gaps in chain-of-custody records that are only discovered during audit. Without standardized documentation and traceability requirements, teams must retroactively construct shipment histories, often without the data needed to confirm that handling and environmental conditions were properly maintained. These risks are not the result of poor execution, but rather of operating without an agreed-upon framework that defines how sensitive materials should be monitored and documented across every stage.
ISO 21973: A Change in Industry Standards
These challenges are not unique to the animal health industry. In 2020, the ISO 21973 standard was introduced to establish standards for the transportation of human cells for therapeutic use. It outlines expectations for maintaining environmental controls, documenting equipment and shipment history, ensuring traceability, managing communication protocols, and mitigating risks such as temperature excursions or breaks in chain of custody. While established specifically for human therapeutics, its principles apply directly to advanced animal health therapies, which face the same vulnerabilities during transport.
Our subject matter experts were founding contributors to the Standards Coordinating Body working group that developed ISO 21973. Their guidance, particularly around managing chain of custody, chain of identity, and chain of condition, draws from our Chain of Compliance® framework, which was established years before ISO 21973. Both rely on clear handling documentation as a verifiable record of how materials were handled throughout transport from origin to destination.
Today, Cryoport Systems is the only supply chain management provider within the life sciences certified to ISO 21973. Our certification ensures that all our services apply the same rigorous, industry-aligned standards across all markets we support.
Operationalizing ISO 21973 throughout the Supply Chain
Cryoport Systems integrates ISO 21973 principles from the moment materials are packaged. Our Cryoport Express® Cryogenic Standard Shipping Systems are engineered to transport highly sensitive materials at cryogenic temperatures. Every shipping system undergoes full requalification before every use, ensuring physical integrity, temperature stability, and performance. Additionally, our Veri-Clean® validated decontamination process removes 99.9999% of external contaminants like bacteria, viruses, and fungi to support biosecurity expectations. Together, these protocols ensure the shipping system meets strict cleanliness and performance standards with every use.
During transit, our integrated condition monitoring systems enable continuous monitoring of temperature, location, humidity, and other critical parameters. All data syncs automatically to our Cryoportal® logistics management platform, giving teams full visibility into conditions throughout transit. Should anything unexpected occur, our logistics experts are alerted 24/7/365 and follow established protocols to protect material integrity and program timelines.
Beyond in-transit oversight, our Chain of Compliance framework maintains complete chain of custody, chain of identity, and chain of condition records across the temperature-controlled supply chain. These audit-ready datasets offer proof that materials were consistently handled from one touchpoint to the next.
Supporting Developers Today with a Forward-thinking Approach
Cryoport Systems applies ISO 21973 to animal health shipments now, exceeding current regulatory expectations and preparing teams in advance for compliance with future requirements. Every step of the transport process is monitored and documented, giving developers a clear view of maintained conditions across sites and geographies. If a deviation occurs, precise timestamped data identifies when and where it happened, enabling rapid intervention before integrity suffers.
Our standards-focused approach safeguards quality today while future-proofing operations to position you ahead of the curve as the regulatory environment evolves. And as operations scale, we have the infrastructure and global reach united under the same quality metrics to keep pace with programs. Teams can work confidently knowing that their transport operations will be fully compliant at every stage both now and in the future.
Consistent handling and documentation are critical for progressing advanced animal therapies from one phase to the next. ISO 21973 provides the structure needed to maintain consistency across the life sciences. With our ISO 21973-certified processes, animal health developers can meet the industry’s highest standards now, well before regulations catch up. This confidence supports scalable development while ensuring cutting-edge therapies reach the livestock and companion animals exactly as intended.
