Cryoport Inc.
10/04/2024 | Press release | Archived content
Certify Safety for Human-derived Materials with Advanced Therapy Shippers®
Certify SafetyforHuman-derived Materials with Advanced Therapy Shippers®
The risk of contamination can compromise life-saving therapies, making it a major concern within the world of transporting precision medicines. Cell and gene therapies require meticulous tracing throughout the supply chain process to ensure that these valuable materials never encounter environmental contagions. When patient lives depend on the quality of these therapies, a logistics provider must have rigorous systems in place to mitigate the risk of contamination throughout the entire journey.
Cryoport Systems understands the criticality and responsibility involved in the management of your valuable materials. We developed our Advanced Therapy Shipper®(ATS) fleet for the exclusive transportation of engineered human cell therapies and human cell and gene therapy research that requires rigorous validation and decontamination protocols. Our ATS fleet is industry-leading when it comes to risk mitigation and goes above and beyond the general standards of compliance to give you peace of mind that your materials will always remain in their optimal condition when in our care.
Dedicated Shippers that Uphold Material Integrity
As an alternative to polystyrene foam and other disposable material, many life science professionals will opt to transport their sensitive cell and gene therapies in reusable shippers. These shippers offer additional protection that single-use shippers can't match. However, being that they are reusable, the same shipper transporting your human-derived therapies could have previously transported non-human materials. In turn, this could increase the risk of cross-contamination from material to material when housed in the same shipping container.
To be truly compliant with ISO 21973, the latest industry standard for transporting cells for therapeutic use, a transport shipping provider should offer an alternative to shipping all commodity types within the same shipping system. There must be solutions in place to ensure the segregation of human and animal-derived materials to prevent any potential cross-contamination (1).The existence of a shipping system specifically designed for human-material usage meets this criterion and ultimately ensures the quality of your commodities is never at risk when placed in a Cryoport Systems' ATS system.
Cryoport Systems' Revolutionary ATS Line
As an important proponent in the creation of ISO 21973, Cryoport Systems places risk mitigation and compliance at the forefront of our support of the life sciences. We designed our ATS line to both meet current industry needs and address future regulatory requirements within the temperature-controlled supply chain. Our ATS systems are the first shipping systems dedicated solely to transporting human-derived materials. They are purposefully segregated from our General Purpose (GP) shipping systems to prohibit any possibility of cross-contamination.
Using the ATS line means you can be sure your human-derived materials won't be placed in a shipper that previously housed non-human based materials. This line also leverages the extensive risk-mitigating features that are encompassed within all our vast lines of shipping systems.
- Extensive Tracking Metrics:Near real-time data about a shipment's internal temperature, external temperature, orientation/tilt, location, and other metrics with our Smartpak® condition monitoring system.
- Uninterrupted Insight: Full visibility of shipments through our Cryoportal®logistics management system and Live View™.
- Integrated Chain of Compliance®: Seamless integration with our comprehensive Chain of Compliance®processes for complete transparency supported by ISO 21973.
- Responsive Team:Support from our knowledgeable team of industry experts, 24/7/365.
As an additional layer of protection, we provide a Certificate of Conformance, which certifies that every ATS system has only handled human cell and gene therapy products.
Ultimate Risk Mitigation through Requalification
Contamination from environmental contagions during the transport process is still a possibility even within material-specific shipping lines. Unforeseen challenges within a shipping lane or simply general wear and tear during the transport process can degrade a shipper over time, making the materials packaged inside vulnerable. To uphold our dedication to setting the industry standard for quality and safety, Cryoport Systems has developed the only shipper requalification process in the life sciences market.
Our unique requalification process encompasses Veri-Clean®, the first and only cleaning and disinfection process that is fully validated by an independent, accredited laboratory. Veri-Clean® virtually eliminates the risk of cross-contamination by decontaminating all our shipper lines, including all ATS systems and stainless-steel accessories, by 99.9999%. This proprietary methodology is supported by rigorous verification that each shipper in our active lines can support the necessary physical sustainability, LN2 capacity, and a minimum required hold time threshold. If any of our equipment doesn't meet the requalification specifications, we immediately remove it from our fleet after a final quality assurance (QA) evaluation. Through this process, you can be sure that your materials - whether human-derived or other - are always placed in shippers that uphold the strictest compliance standards.
When it comes to advanced therapies, precision and integrity defines the difference between hope and heartbreak, making selecting the right shipping system of the utmost importance. Cryoport Systems' ATS line is the most reliable defense in preventing any potential for cross contamination of material types between shippers. By ensuring absolute segregation of the ATS fleet, unparalleled cleanliness and quality, and continuous monitoring, our ATS line provides a new standard of security. For transporting the therapies that shape the future, you can trust in the risk mitigation that only Cryoport Systems can deliver.
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