As Long As We Are Having Fun and Speculating This Weekend

Speaker at ISBiotech, March 6-8, 2017 : (http://www.isbiotech.org/pdfs/Spring2017PAAG.pdf)

Martin A. Giedlin, PhD

Executive Director, Process Development Novartis Pharmaceuticals Corporation

Bench to Commercial-Scale Process Development for a CAR T-Cell Therapy Abstract Autologous gene-modified adoptive cell therapy is a rapidly emerging option for treatment of refractory/relapsing leukemias and lymphomas. Numerous clinical trials have demonstrated that the use of chimeric antigen receptors (CARs) or modified T-cell receptors (TcRs) targeting these malignancies have a remarkable ability to traffic, expand, and kill target tumor cells post-infusion. However, there are a number of challenges to overcome in order to ensure the safety and efficacy of these cellular-based immunotherapies in a commercial setting. Characterization and control of patient leukapheresis starting material, vector for delivering the target gene, optimal activation/expansion conditions, and in some cases, cryopreservation process and stability, all need to be defined and controlled. This presentation will review an approach utilized to progress these therapeutics from academia to commercial manufacturing and highlight the roles of process development, characterization, and validation, specifically, within the context of a CD19 targeted CAR T immunotherapy. Biography Now look at his former employer: Sangamo Biosciences http://podcasts.ibclifesciences.com/CellTherapy/2014/IBC_B14188_Giedlin.pdf