PREPARING FOR COMMERCIAL MANUFACTURING OF AN AUTOLOGOUS CELL THERAPY
- A conversation with Jonathan Tsang, Kite Pharma, a Gilead Company

Jonathan Tsang, senior director, MSAT, Kite a Gilead Company, shares his experiences and provides advice on how autologous cell therapy companies can better prepare for commercial manufacturing, including: (1) Addressing the challenge of variability of patient cell behavior; (2) Process development characterization using healthy donor vs. patient cells; (3) Volume and logistical complexity of personalized therapy; (4) Planning and implementing of fast and efficient business systems to support scale-out

IMPLEMENTING AN EFFICIENT ALLOGENEIC MANUFACTURING
– A conversation with Marty Giedlin, SentiBio

Marty Giedlin, vice president and head of technology operations at Senti Bio shares his experiences and provides advice on how allogeneic cell therapy companies can implement better manufacturing strategies, including; (1) Understanding and managing manufacturing expectations; (2) Letting the science drive your strategy; (3) CMC must be driven by the data; (4) Characterizing starting materials – be confident or don’t do it; (5) Why a “one size fits all” process is not realistic

A MULTI-PRODUCT CELL THERAPY FACILITY
– A conversation with Stephen Judd, Arcadis/DPS Group

Stephen Judd, Process SME – Biologics and Cell Therapy, Arcadis/DPS Group shares his experiences and provides advice on how cell therapy companies should approach a multi-product facility design, including: (1) Autologous vs Allogeneic design considerations; (2) Implementing proper equipment design and cleanroom grading; (3) Operational challenges impacting facility design; (4) Essential multi-modal facility layout considerations; (5)Case study: A multi-product autologous CAR-T facility