EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients

The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.

3D illustration of T cells attacking a cancer cell (CAR-T cell therapy) - Illustration
Out Of Specification Issues Pose A Unique Challenge For CAR-T Therapies • Source: Shutterstock

The European Medicines Agency has issued guidance explaining how manufacturers of cell- and tissue-based therapies, such as chimeric antigen receptor T-cell (CAR-T) products, should deal with "out of specification" batches once the product is granted marketing authorization.

Production of out of specification (OOS) batches is a unique post-marketing issue faced by commercial autologous cell therapies, an

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