CELL THERAPY STRATEGIES

Cell Therapy Manufacturing Strategies: Autologous vs. Allogeneic

December 15, 2022, 11am-1:30pm ET, Online and Interactive

There have been tremendous advancements and breakthroughs in cell therapy treatments. Autologous treatments are extremely effective personalized therapies, but have significant medical, cost and commercialization limitations. Allogeneic treatments provide us with an opportunity to expand and extend access to personalized therapies to patients in need, but face efficacy, safety, and process hurdles.

While related, the differences are stark, forcing your company to make unique and critical process and business decisions to ensure your company implements the best technologies to execute the most effective autologous and/or allogeneic cell therapy manufacturing strategy.

Meeting Agenda (all times ET and subject to change)

Moderator: Ben Locwin, Executive, Black Diamond Networks

11:00am – 11:15am: Welcome + Meet and Greet Networking

11:15am – 11:40am: Conversation #1: Preparing for Commercial Manufacturing of an Autologous Cell Therapy

(Jonathan Tsang, Senior Director, Manufacturing Sciences and Technology, Kite Pharma)

• Addressing the challenge of donor cell behavior
• Predicting cell, raw material variability
• Establishing and executing proper chain of custody
• Building state-of-the-art IT systems into the process
• Planning and implementing efficient business systems to support scale-out

11:40am – 12:05pm: Conversation #2: Implementing an Efficient Allogeneic Manufacturing Strategy

(Marty Giedlin, Vice President, Head of Technology Operations, Senti Bio)

• Understanding and managing manufacturing expectations
• Letting the science drive your strategy
• CMC must be driven by the data
• Characterizing starting materials – be confident or don’t do it
• Why a “one size fits all” process is not realistic

12:05pm – 12:30pm: Conversation #3: Multi-Modal Facility Design Considerations for Cell Therapy

(Stephen Judd, Process SME – Biologics and Cell Therapy, DPS Group Global)

• Autologous vs Allogeneic design considerations
• Implementing proper equipment design and cleanroom grading
• Operational challenges impacting facility design
• Essential multi-modal facility layout considerations

12:30pm – 1:30pm: Deep Dive Networking

*partial attendee list