THE POWER OF PROCESS KNOWLEDGE: BUILDING WORKFLOWS TO ACHIEVE PREDICTABLE MANUFACTURING OUTCOMES WORKSHOP
Sponsored by Sartorius
{Gaudi 3}
4:15pm – 5:00pm
The recent success of cell-based therapies is generating momentum to overcome bottlenecks in bringing these innovative therapies to market faster. Traditional approaches often rely on manual operations that lead to insufficient process and cell characterization and ultimately extend development time. Further, disjointed workflows across upstream, downstream, and data analysis processes impede the generation of critical insights for future scale-up. Building process knowledge is foundational to developing streamlined workflows throughout R&D, process development, and manufacturing to deliver on the promise of cell-based therapies. Join this session to hear from experts on:
– Building a framework early in development to achieve clinical goals
– The importance of gaining process knowledge to reduce product variability
– Designing scalable workflows that maintain cell product quality
Chair:
Andres Castillo, Cell and Gene Process Manager, Sartorius
Speakers:
Jessica Carmen, Ph.D., Business Development Advisor, Oxford Biomedica
Jason C. Foster, CEO and Executive Director, Ori Biotech
François Gianelli, Pharm.D., Senior Director, CMC and Quality, Voisin Consulting Life Sciences
Andy Holt, Chief Commercial Officer, Ncardia
David Smith, President and Chief Commercial Officer, Akron Biotech