CellPryme-M question, page-16

The FDA released a draft guidance document in March titled Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. As is standard with FDA draft guidance documents, comments were invited. In this case, comments needed to be submitted by this week (14/06/22). After considering all submissions, the FDA begins work on a final version of the guidance document.

In this draft guidance, the FDA provides CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.

In CMC Recommendations, Section D, guidance is provided on Managing Manufacturing Changes and Assessing Comparability During the CAR T Cell Product Life Cycle .

In Preclinical Recommendations, Section E, the FDA addresses CAR T Cells with Additional Modifications.

https://www.fda.gov/regulatory-info...chimeric-antigen-receptor-car-t-cell-products