CELL LINE OPTIMIZATION: LEVERAGING TECHNOLOGY TO IMPROVE SPEED, QUALITY, COST
Welcome
Today’s goal is to learn from three cell therapy analytical and CMC experts who have all "walked the talk." The goal is to tap into their personal experiences and advice so your company can improve process efficiency and accelerate approval success. Experts Yeh-Chuin Poh (Beam Therapeutics), Bruce Thompson (Resilience) and Akshata Ijantkar (BMS) have agreed to sit down 1:1 with fellow cell therapy expert Dominic Clarke (Discovery Life Sciences) to discuss: (1) Identifying and Overcoming CMC Challenges; (2) Key Analytical Challenges for Cell Therapy; and (3) Developing and Executing Proper Flow Cytometry Assay Development Strategies.
CELL THERAPY ANALYTICS - A Conversation with Yeh-Chuin Poh
Poh, senior director, cell therapy process development at Beam Therapeutics shares his experiences and provides his advice on how cell therapy companies can better identify and overcome CMC challenges, including: (1) Balancing continuous process innovation and the FDA; (2) Implementing a proper comparability strategy; (3) When to make pivotal product changes; (4) Process standardization – what’s possible and what’s appropriate.
CELL THERAPY ANALYTICS – A Conversation with Bruce Thompson
Thompson, most recently served as vice president and technical lead for the cell therapy franchise at Resilience, shares his experiences and provides his advice on how cell therapy companies can address key analytical challenges, including: (1) Identifying proper analytical development timelines; (2) Understanding product biology to develop proper potency assays; (3) Staying current on the rapid safety testing landscape; (4) The latest iterations and most exciting new analytical techniques.
CELL THERAPY ANALYTICS – A Conversation with Akshata Ijantkar
Ijantkar, senior principal scientist, CMC team lead, cell and gene therapies at Bristol Myers Squibb, shares her experiences and provides his advice on how cell therapy companies can develop better flow cytometry assay strategies for cell therapies, including: (1) What is/isn’t phase appropriate; (2) Understanding regulatory implications; (3) FMO controls - why you need them; (4) Qualification attributes – How many experiments is enough.
