Content

A Roadmap for the Development of a Chimeric Antigen Receptor T Cell (CAR T) Product

Part of the BTEC Spring 2025 Seminar Series

Friday, Mar. 28, 2025
10:40–11:30 a.m. EST
BTEC room 135

Speaker

Bruce Thompson
CTO
Kincell Bio

The pathway to developing a clinical CAR T asset includes many key milestones. We’ll discuss these concepts, including construct definition, engineering elements and raw material considerations, CMC (Chemistry, Manufacturing and Controls) activities to prepare a product for a GMP manufacturing campaign to support an IND (Investigation New Drug) filing with the FDA. Building on an understanding of the baseline cell biology, development of a CAR T asset focuses on defining the TPP (Target Product Profile) and then establishing manufacturing process and analytical testing strategies to consistently produce these products for patients.