Cryoport’s Temperature Controlled Logistics Solutions Supporting Regenerative Medicine Advanced Therapy (RMAT) Clinical Development

Mon, Aug 27, 2018 | By Colin Coffua, Vice President of Strategic Cryoport

Cryoport’s unique range of Cold Chain Logistics Solutions have been developed and implemented to support the most important and advanced drugs currently in the clinical development portfolios of many of the leading global biopharmaceutical companies and those that have been commercially approved – Novartis’ KYMRIAH™ and Gilead/Kite’s YESCARTA™. With the criticality of ensuring the highest quality, service and transparency to support the clinical and commercial aspects of each drug, Cryoport provides solutions that provide Chain of Custody, Condition, Identify and most important Chain of Compliance™ ensuring “zero defect” for the transportation and delivery of each lifesaving drug. Cryoport has worked closely with all our client partners to ensure maximum success in a complex environment. The dramatic increase of compounds being investigated in Regenerative Medicine over the last few years has required increased attention to supply chain requirements than ever before. Cryoport is proud to be partnered with the leading biopharmaceutical companies exploring the most advanced medical cures in the world.

Cryoport’s alliance with these Medical Pathfinders is based on the establishment of the U.S Congress’ “21st Century Cures Act” and initiation by the Food and Drug Administration (FDA) of The Regenerative Medicine Advance Therapy (RMAT) designation in December 2016. An RMAT designation is awarded by the FDA to Biopharmaceutical companies to shorten the time needed to review, approve, develop and market innovative regenerative medicine products within the country.

The FDA has designated that a drug is eligible for RMAT designation if it:

  • Is a cell therapy, therapeutic tissue engineered product, human call and tissue product, or any combination product using such therapies or products.
  • If a drug is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition.
  • If the drug has the potential to address unmet medical needs for a disease or condition.

The FDA has also identified other products that are eligible for RMAT designation. These include:

  • Cell Therapies
  • Gene Therapies
  • Therapeutic tissue engineered products
  • Human cell and tissue products
  • Combination products using such therapies or products.

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As of the mid-point of 2018, a total of 20 products have been awarded the FDA’s RMAT designation. Since 2017, Cryoport has been supporting the cold chain and cryogenic logistics requirements for most of the high-profile compounds in clinical development that have the RMAT designation. Those clients include Bluebird Bio, Capricor Therapeutics, Juno Therapeutics, and Mesoblast to name a few. As the demand for lifesaving drugs and personalized medicine accelerates, along with increased innovation in CAR-TCR development, the demand for temperature-controlled logistics solutions will increase accordingly.

Written by: Colin Coffua, Vice President of Strategic Cryoport  

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