Standardizing Best Practices For Transporting Cell And Gene Therapies

By Mark Sawicki, Ph.D., Chief Commercial Officer, Cryoport, and Robert Jones, Vice President, Global Bioservices, Cryoport

With any new high-tech industry that’s growing very rapidly, standards often lag, and this has been the case for the manufacture and distribution of cell and gene therapies. The industry determined that the establishment of new standards for the transportation of these advanced therapies has become a necessity since these products are considerably more sensitive to their environment during transit than more conventional therapies. For traditional biologics and small molecule products, there is a significant allowance for time out of environment (TOE), but in the cell and gene therapy space, the TOE tolerance is essentially zero. As such, the existing paradigms used for pharmaceutical distribution are not appropriate, and it was necessary to redevelop methodologies from a distribution standpoint that would eliminate those a4llowances for TOE and similar criteria and be significantly more rigorous.

This article reviews the development of new ISO standards, compliance considerations that require paradigm shifts, and additional standardization.