Cold Chain Planning for Regenerative Medicine Clinical Studies

November 01, 2016

The advent of regenerative therapy — a field that includes gene therapy, gene editing, stem cell therapy and immuno-oncology — is creating an unprecedented need for cold chain logistics. According to the Alliance for Regenerative Medicine, there are 70 approved cell therapies currently being marketed and at least 728 ongoing regenerative medicine clinical trials involving thousands of patients for a variety of clinical indications. Although manufacturers go to great lengths to ensure that their highly valuable products are produced under rigorous standards, they may fail to adequately consider these standards when planning the logistics of handling, packaging or transporting materials from one location to another. In this article, Mark W. Sawicki, Ph.D., Cryoport’s chief commercial officer, examines the need for comprehensive cold chain planning for clinical studies in regenerative medicines, and he details current best practices. Read more >

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Tags: Clinical Trials Logistics, Temperature Controlled Logistics, Frozen Biological Shipping