Considerations To Get Your CAR T Testing Strategy Right

By David Colter, Ph.D., Sr. Director of Analytical Development, Center for Breakthrough Medicines

What CAR T Innovators should take away from the FDA’s March 2022 Draft Guidance

Less than five years after the first approval of a CAR T therapy in 2017, momentum for CAR T and other cell therapies has never been greater.

Given their experience reviewing and approving six CAR Ts across 10+ indications, the FDA released a draft guidance “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products” in March of 2022. As a trusted partner to cell therapy product developers such as Achilles Therapeutics, we at the Center for Breakthrough Medicines (CBM) identified three considerations – testing CAR-T starting material, establishing manufacturing process controls, and implementing robust testing analytics – that our clients prepare for as part of their analytical development prior to finalization of the guidance. This will help to monitor and report on the right critical quality attributes (CQAs) of their CAR T products which is needed for characterization of the product’s safety and efficacy that is reported to health authorities.

In this article, review these three considerations and how to continue to invest in analytical development and testing capabilities.