Panelists:
Pascal Touchon
Board Member–RoslinCT Global Strategy Advisor
RoslinCT
Heath Coats
Senior Principal
Head of Quality & Compliance
Dark Horse Consulting Group
Gregory Russotti, PhD
Chief Technology and Manufacturing Officer
Century Therapeutics
Jay Kang, PhD
Executive Director of CMC and External Manufacturing
Legend Biotech
Dean Morris
Chief Operations Officer
RoslinCT (U.S.)
- Time:
Today’s cell and gene therapy developers face a new set of manufacturing pressures. As clinical pipelines expand, there is a widening commercial readiness gap emerging, with many programs still relying on processes and infrastructure designed for early-phase production. Simultaneously, the prospect of treating larger patient populations strains existing manufacturing models, raising urgent questions about how prepared the sector is for commercial scale production.
In this GEN webinar, experts in cell and gene therapy manufacturing will examine the drivers behind the growing disconnect between clinical success and commercial viability and explore why addressing this transition is essential. They will discuss critical technical and strategic considerations that shape readiness for licensure, including process and analytical strategy, comparability planning, raw material selection, and facility design, as well as how the industry is preparing to handle larger indications and what this means for future manufacturing approaches. Key takeaways from the webinar include:
- Regulatory expectations for therapies approaching approval and how manufacturing strategies influence regulator confidence.
- Practical insights into how developers can reduce risk and build manufacturing models that support long term commercial success from case studies of previously approved cell therapies and established modalities like biologics.
A live Q&A session followed the presentation offering a chance to pose questions to our expert panelists.
Produced with support from:


