Setting the Benchmark for Quality in Cell and Gene Therapy Logistics
Quality in cell and gene therapy (CGT) is the foundation that determines whether a therapy reaches a patient intact and effective. As the industry increasingly scales from early development of CGTs to global commercialization, the margin for error narrows as volume and complexity increase. Standards like ISO 21973 provide a framework, but true industry leadership comes from how those standards are applied. In this, Cryoport Systems is setting that benchmark.
Why Quality is the Cornerstone of CGT Supply Chains
Cell and gene therapies are wholly unique in that they are living cellular products with strict environmental requirements, unlike traditional pharmaceuticals. Under these circumstances, a single temperature deviation or point of cross-contamination can compromise the viability of the treatment. For patients anxiously waiting for advanced therapies with the potential to change or save their lives, this risk is unacceptable. Because of this, quality goes beyond meeting minimum requirements and instead means building robust systems that anticipate challenges and eliminate variability. These systems are wholly unique to these sensitive materials, and the traditional supply chains of the past are being reimagined in real-time to keep up.
The complexity involved in CGT supply chain logistics only grows as programs scale through each phase of development. Pre-clinical programs often involve small volumes and short timelines, but require the same level of care and precision, especially since the success of moving into the next phase hinges on early successes and robust quality systems designed for forward compatibility. Early-stage clinical trials introduce additional complexities and regulatory expectations. As trials scale into Phase II and Phase III, the introduction of additional sites and geographies introduces further complexities and regulatory expectations. At commercial scale, therapies frequently move across borders and through diverse regulatory environments. Maintaining quality and consistency throughout these transitions requires a supply chain that is both standardized and adaptable, built to flex as programs scale.
What Benchmarking Looks Like in Practice
Setting the benchmark for quality requires a measurable commitment to processes that deliver both consistency and reliability. For Cryoport Systems, this begins with ISO 21973 certification to ensure compliance with the most rigorous global standard for transporting cells for therapeutic use. This level of certification validates that our systems and processes meet requirements for critical parameters like environmental control, equipment validation, and documented communication protocols. It also confirms that we have implemented processes to minimize risks like temperature excursions or chain-of-custody breaches.
Beyond certification, benchmarking means integrating these principles into every aspect of our operations. Our proprietary Chain of Compliance® framework preserves historic equipment and shipment data for a decade or longer, creating an audit-ready record that supports regulatory confidence. Every shipping system undergoes full requalification before each use to confirm performance. Our unique Veri-Clean® decontamination process is the industry’s only independently validated protocol, proven to eliminate 99.9999% of external contaminants (including bacteria, viruses, and fungi), ensuring biosecurity for sensitive materials. Continuous monitoring via integrated Smartpak™ sensor technology in every shipping system tracks temperature, location, and other critical parameters throughout transit, providing transparency at every stage with full visibility into performance data directly in our Cryoportal® logistics management platform.
Why This Matters
For CGT developers, quality is directly tied to both risk mitigation and operational efficiency, as a shipment failure could mean delays in clinical trials or an impact on patient outcomes. By setting the benchmark for quality, Cryoport Systems mitigates these risks and ensures scalability as programs transition from pre-clinical development to clinical trials and ultimately to global commercialization. Our ISO 21973-certified processes support this growth, ensuring that logistics never become a roadblock.
This also influences regulatory readiness, as organizations that proactively align with ISO 21973 (currently the industry’s most stringent standard) are better positioned for future compliance. This can help to accelerate approvals and streamline global distribution strategies as programs progress into additional geographies, maintaining consistency at every step.
Leadership Through Action
Cryoport Systems didn’t wait for ISO 21973 to become a requirement. We helped shape the standard and adopted its principles long before certification was available. Today, as the first and only global supply chain solutions company certified under ISO 21973, we demonstrate what leadership looks like in practice. Our commitment to quality isn’t static. It evolves with the industry, anticipating challenges and delivering solutions that protect the integrity of every therapy we handle.
Setting the benchmark for quality is not a one-time achievement for us. It’s an ongoing responsibility. As regenerative medicines advance, the logistics that support them will only become more complex. Cryoport Systems is prepared for that future. By combining ISO 21973 certification with continuous innovation, we provide a comprehensive, end-to-end supply chain platform that both meets the highest standards today and adapts to tomorrow’s demands.
