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Moving Your Therapies to Market?Trust Cryoport

The Cell and Gene Industry Is Growing Faster Than Ever Before

“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.

A Patient is Waiting

Cryoport ensures advanced therapies reach patients safely - traceability, transparency, and regulatory compliance are standard.

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Cryoport is the only end-to-end temperature-controlled logistics partner you can trust.

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We mitigate risk and ensure the integrity of your materials — from development through commercialization.

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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.

Our clients have trusted our team and technology to deliver traceability, transparency, and regulatory compliance in:
668 Active Clinical Trials
12 Commercial Products
665,000+ Shipments
150+ Countries

Ensuring Advanced Therapies Reach Patients Safely

Because at Cryoport, traceability, transparency, and regulatory compliance are standard.

Guaranteed Full Traceability and Transparency With Robust Data Management

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.
Chain of Compliance
Advanced Therapy Shippers

Setting New Standards With the First and Only Human Use Only Fleet

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.

Veri-Clean®: Thorough and Powerful Cleaning and Validation Procedures

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:

  • Reduce external contaminants by 99.9999%
  • Result in 6-log drop of tested biological indicators
  • Reliably verify no environmental flora — including bacteria, fungi, and viruses — are present
  • Manually confirm the shipper is free from protein and hemoglobin
Validated Cleaning

Staying Ahead of Changes in Regulatory Compliance 

Because as the industry evolves, we will too.

Compliance Unified Ecosystem® (CUE)

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:

  • Streamlining all chain of identity, custody, compliance, and condition requirements
  • Supporting shared informatics platforms
  • Providing better visibility and control of the drug substance collection, drug product manufacturing, distribution, reimbursement, and outcomes research
CUE

Our Commitment to Continuous Innovation

Connect with our team to learn more about how we can support your organization in changing the future of medicine.

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Free White Paper
Advanced Therapy Shipper

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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