USA – FDA issues guidance on cell, gene therapy manufacturing

Manufacturers of cell and gene therapies have a new guidance from the US Food and Drug Administration (FDA) that provides pandemic-related manufacturing considerations.

The guidance specifically addresses both licensed and investigational cell and gene therapy (CGT) manufacture, and “is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s ‘Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry’ issued in June 2020,” according to the guidance.

Industry-specific issues addressed in the guidance include cells and tissues recovered from donors and the particular methods by which a CGT product will be manufactured, such as cell expansion, viral reduction steps, and formulation. The guidance applies to CGT products regulated as drugs and biologic products alike, but not to devices or human cells, tissues, and cellular- or tissue-based products (HCT/Ps) regulated under section 361 of the PHS Act…