Driving Compliance and Standardization in CGT Supply Chains
As cell and gene therapies (CGTs) continue to advance and more therapies reach late-stage clinical trials and commercialization, the complexity of the related logistics is only increasing. Therapies are crossing borders, reaching broader patient populations, and expanding into global distribution, all of which introduces risk if standards are inconsistent. Compliance and standardization, as a result, are essential for ensuring both scalability and patient safety.
The Compliance Challenge
The current regulatory landscape for advanced therapies is fragmented. Requirements vary across regions, and interpretations of standards differ among stakeholders. This lack of harmonization creates operational inefficiencies while, at the same time, increasing the potential for errors. For sensitive therapies that rely on precise environmental conditions, even slight deviations can have severe consequences.
True compliance doesn’t just meet today’s rules but actively anticipates what regulators are likely to expect tomorrow. As global authorities look for ways to unify standards, ISO 21973 has emerged as a critical reference point. Organizations that align with this standard now are better positioned to easily navigate future requirements with confidence.
ISO 21973 as a Unifying Framework
ISO 21973 was designed to address the unique challenges of transporting cells for therapeutic use. It establishes clear requirements for things like environmental control, equipment validation, and documented communication throughout the temperature-controlled supply chain. By defining these elements, the standard reduces variability and creates a foundation for global consistency.
For cell and gene therapy developers, this framework simplifies compliance across multiple jurisdictions, providing a common language for logistics partners, regulators, and manufacturers alike. This level of clarity and alignment can help to accelerate approvals while supporting the scalability needed to bring therapies to patients around the world.
Cryoport Systems and the Compliance Imperative
Cryoport Systems is the first and only global supply chain solutions company certified under ISO 21973. This certification validates our long-standing commitment to meeting the highest standards for safety and reliability, and also reflects our role in defining excellence in the industry. In fact, we don’t just adhere to this standard; we actively participated in its development through our work with the Standards Coordinating Body working group.
Compliance at Cryoport Systems isn’t a static achievement marked by the receipt of a certification. It’s a continuous process supported by rigorous protocols and an ongoing culture of excellence. Every shipment benefits from validated shipping systems, requalification of equipment before use, and Veri-Clean® decontamination to eliminate external contaminants like bacteria, viruses, and fungi. Our Cryoportal® logistics management platform provides continuous monitoring and historic data of shipment conditions, tracking critical parameters like temperature, location, humidity, shock, tilt, among others. This ensures transparency and accountability at every stage, supporting regulatory considerations and ensuring audit-ready documentation.
Benefits Beyond Compliance
For advanced therapy developers, ISO 21973 compliance delivers regulatory assurance and reduces operational complexity by standardizing processes across regions. It mitigates risk by ensuring therapies arrive in optimal condition (with the documented condition monitoring to validate). And it supports global expansion by providing a supply chain compliance framework that regulators recognize and trust.
These benefits apply across all phases of development. In early-stage programs, compliance builds a foundation for scalability. Throughout clinical trials, it streamlines coordination among sites as trials expand. And at commercial scale, it enables consistency and standardization across diverse markets.
Standardization is the key to unlocking the full potential of advanced therapies. As the industry grows and more CGTs become commercially available, the need for harmonized processes will only intensify. Cryoport Systems is leading that effort by combining ISO 21973 certification with a culture of continuous improvement. Ultimately, our goal is straightforward. We are Enabling the Outcome™ by providing the industry’s most comprehensive, end-to-end supply chain platform, which adheres to the most stringent standards today and is ready to meet the demands of tomorrow.
