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US FDA Pressing Industry To Use Standards For Cell and Gene Therapies

 
• By Joanne S. Eglovitch

A US FDA official is exhorting the biopharmaceutical industry to adopt standards to help in developing new cell and gene therapy products, yet this may pose difficulties as there is a lack of standards in this space, particularly in areas such as cell viability, chain of identity and viral vector gene quantification.

3D illustration of T cells attacking a cancer cell (CAR-T cell therapy) - Illustration

Industry should rely more on standards for new cell and gene therapy products because it could ease the development and approval process, a US Food and Drug Administration official told a recent conference, though it may be easier said than done given the "critical need" for more standards in the regenerative medicines area that a recent report identified.

Officials from the FDA’s Center for Biological Evaluation and Research discussed some of the agency’s initiatives now underway to promote the use of standards in developing cell and gene therapies at the recent CASSS cell and gene therapy meeting in Bethesda, MD

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