A Patient is Waiting
Cryoport ensures advanced therapies reach patients safely - traceability, transparency, and regulatory compliance are standard.
“We anticipate that the number of product approvals for cell and gene therapies will grow in the coming years ... by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year.”
– Scott Gottlieb, former FDA commissioner
The industry’s newfound confidence in the potential of cell and gene therapies has produced a surge in investigational new drug (IND) applications.
The approval of the first cell therapy in 2017 has marked an official transition from experimental research to commercial production. As a result, companies are scaling up advanced therapy research services and manufacturing processes to support the movement of life-changing advanced therapies through to commercialization. We recognize this shift and have committed to supporting your journey with innovative global supply chain solutions dedicated to advanced therapies.
Cryoport ensures advanced therapies reach patients safely - traceability, transparency, and regulatory compliance are standard.
Cryoport is the only end-to-end temperature-controlled logistics partner you can trust.
We mitigate risk and ensure the integrity of your materials — from development through commercialization.
Our comprehensive logistics platform, powerful informatics, and 24/7/365 customer support are unmatched.
At Cryoport, our mission is to provide reliable and comprehensive temperature-controlled cold chain logistics solutions. We have been managing the care and transfer of the most critical shipments since 2008, delivering valuable materials to researchers, manufacturers, biopharma partners, and their patients worldwide.
Because at Cryoport, traceability, transparency, and regulatory compliance are standard.
Our Chain of Compliance® process provides full traceability of the equipment and processes used in managing the environmental control of your samples. This includes full transparency regarding equipment performance, commodity history, equipment requalification, calibration history, and the correlation of in-field events.
Our new Advanced Therapy Shipper™ (ATS) product line is an innovative first-to-market fleet dedicated exclusively to advanced cell and gene therapy supply chain management for both clinical and commercial therapies. We guarantee your shipper has never contained non-human-based materials, virtually eliminating the possibility of cross-contamination.
Our new and validated cleaning and disinfection process, Veri-Clean® , virtually eliminate the risk of cross-contamination of materials. With support from a third-party vendor, we guarantee our cleaning procedures:
Because as the industry evolves, we will too.
Cryoport is at the forefront of developing a network of products, partners, processes, and systems that will support a Compliance Unified Ecosystem® (CUE). This ecosystem becomes essential for the development of scalable, standardized, and compliant logistics and supply chain solutions for regenerative therapy commercial programs by:
Connect with our team to learn more about how we can support your organization in changing the future of medicine.
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A Leap Forward in Standardizing the Regenerative Medicine Supply Chain – What the New ISO 21973 Guidance Means for Cell and Gene Therapy Developers
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