Beyond the Box: Why Shipping System Qualification Matters in Advanced Therapies
For advanced therapy logistics, quality isn’t limited to what happens inside the manufacturing suite. It extends across the entire supply chain, from packaging and transport to the systems that safeguard material integrity at every handoff. Yet one of the most critical (and often underestimated) steps in ensuring integrity is a shipping system qualification.
Shipping system qualification confirms that the equipment, materials, and processes used to transport temperature-sensitive therapies like cell and gene therapies (CGTs) can consistently perform under real-world conditions. For advanced therapies like these, where every shipment may represent a single patient’s treatment, qualification is fundamental to protect product integrity and regulatory compliance.
Every Shipping System Needs Proof of Performance. Why?
The reliability of a shipping system can’t be taken for granted. The impact of environmental variation, handling differences, and product pack out need to be assessed and understood. Without qualification, there’s no data-driven assurance that the system will maintain temperature stability and physical protection throughout transit.
A properly qualified shipping system provides that assurance. It demonstrates, through controlled testing and documentation, that the equipment will perform as expected under defined conditions and across uses. It also establishes baseline performance data for comparison, which is important for ongoing compliance and risk management.
In short, qualification transforms assumptions into evidence.
Preparing for the Unexpected with Qualified Backup Systems
Even the most robust logistics strategy must plan for the unexpected. A delayed shipment, damaged shipper, or sudden increase in demand can require an immediate backup solution. This is especially true if your logistics partner is operating within a framework that cannot accommodate quick turn upon request (deployment within 24 hours or less from order). Without pre-qualified alternatives in place, organizations face difficult choices that can compromise timelines.
Qualifying backup systems ensures continuity without compromise. It enables operations teams to respond swiftly to disruptions or rush requests, knowing that each alternate system has been tested, documented, and approved to meet the same performance and compliance criteria as the primary.
This proactive approach reduces risk, protects patient material, and demonstrates to regulators that the organization is prepared for contingencies.
Qualification as a Foundation for Compliance
Regulatory agencies expect objective evidence that every component of the shipping process performs as expected. Qualification provides that evidence through documented studies, test data, and clear acceptance criteria.
When qualification is overlooked or inconsistently applied, organizations face greater exposure to deviations, investigation cycles, and shipment delays. But a documented qualification program that covers both primary and backup systems creates operational consistency and inspection readiness. It also builds trust across the supply chain, reinforcing confidence that products will arrive in spec and on time.
Expert Advisory Support for Packaging Qualification
For organizations looking for support with shipping system and packaging performance qualification, our Consulting and Advisory Services offer comprehensive performance qualification services that evaluate your transportation, handling, and distribution processes, helping you strengthen your supply chain and ensure your packaging and shipping solutions can withstand real-world conditions while maintaining the integrity of your valuable biologics.
Our expert team conducts extensive physical and thermal performance tests, adhering to industry standards such as ISTA, ASTM, and IATA. We design and execute qualification studies tailored to product and lane requirements, establish clear acceptance criteria, and develop qualified secondary and tertiary packaging for contingency use.
Whether you’re qualifying new packaging for global clinical shipments or establishing a backup program for commercial distribution, our qualification services provide you with the technical depth and operational infrastructure to support your regulatory filings.
We’re here to help you make sure you get it right the first time.
Qualification Defines Readiness
As advanced therapies progress toward larger-scale commercialization, logistics reliability becomes a critical quality attribute. Qualification of both primary and backup systems is what shifts a supply chain from functional to resilient.
It’s not just about the box. It’s about proving that every system, every shipment, and every decision in the supply chain stands up to scrutiny.
Cryoport Systems helps clients build that confidence through proven qualification programs, a fully traceable fleet, and a global Chain of Compliance® that protects product integrity at every step.
