Concurrent Session: Point-of-Care (POC) - Nuts and Bolts: QC Testing
Saturday, September 9, 2023 11:00 AM - 12:00 PM
335 AB
Chair
Rupa Pike, PhD, Catalent Pharma Solutions, USA
Speakers
Stephanie Mgebroff, MSc, Seattle Children's Therapeutics, USA – Standardization and Collaboration: Considerations for developing an optimized QC testing platform for early-phase manufacturing
Anushree Anil Datar, MSc, Children's National Hospital, USA – Using QC testing for virus-specific T cells as a guide for developing point of care QC testing
Larry Bellot, PhD, Charles River Laboratories, USA – Challenges to Building A Robust QC Testing Program
Much of the focus for POC manufacturing is around the manufacturing of the cells, but QC and analytics play a key role as well and are much less automated. This session will provide insights into challenges associated with developing and implementing robust, standardized and reproducible QC testing strategy.
Session Objectives
Rupa Pike, PhD, Catalent Pharma Solutions, USA
Speakers
Stephanie Mgebroff, MSc, Seattle Children's Therapeutics, USA – Standardization and Collaboration: Considerations for developing an optimized QC testing platform for early-phase manufacturing
Anushree Anil Datar, MSc, Children's National Hospital, USA – Using QC testing for virus-specific T cells as a guide for developing point of care QC testing
Larry Bellot, PhD, Charles River Laboratories, USA – Challenges to Building A Robust QC Testing Program
Much of the focus for POC manufacturing is around the manufacturing of the cells, but QC and analytics play a key role as well and are much less automated. This session will provide insights into challenges associated with developing and implementing robust, standardized and reproducible QC testing strategy.
Session Objectives
- Insights into complexities of developing QC testing strategy for early-stage clinical trials including phase-appropriate approach.
- Overview of optimizing QC testing at POC using real-world case study.
- Opportunities to leverage CDMO best practices and adapt them to the POC cell therapy manufacturing.
Nirupama Pike PhD
Sr. Director, Global Head of Strategic Alliances and Field Scientists, Cell Therapy
Catalent Pharma Solutions
Chair
Sr. Director, Global Head of Strategic Alliances and Field Scientists, Cell Therapy
Catalent Pharma Solutions
Chair
