An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment aspects of CAR-T and TCR-T Cellular Therapies Development.

CAR-T therapies have shown remarkable efficacy against hematological malignancies in the clinic over the last decade and new studies indicate that progress is being made to use these novel therapies to target solid tumors as well as treat auto immune disease. Innovation in the field including TCR-T, allogeneic or "off the shelf" CAR-T and autoantigen/armored CAR-Ts are likely to increase the efficacy and applications of these therapies. The unique aspects of these cell-based therapeutics; patient derived cells, intracellular expression, in vivo expansion, and phenotypic changes provide unique bioanalytical challenges to develop PK and immunogenicity assessments. The international Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Translational and ADME Sciences Leadership Group (TALG) has brought together a group of industry experts to discuss and consider these challenges. In this white paper, we present the IQ consortium perspective on the best practices and considerations for bioanalytical and immunogenicity aspects towards the optimal development of CAR-T and TCR-T cell therapies.