Seamlessly Integrating New Raw Materials into CGT Manufacturing, an End-to-End Qualification Strategy
Time: 2:00 pm
day: Pre-Conference Workshop Day
Details:
As cell and gene therapies evolve, so too does the complexity of their raw material requirements. Introducing a raw material into an existing CGT process demands a coordinated approach across technical, quality, regulatory, and supply chain functions. This session will cover an end-to-end frame work of adding a new supplier into your manufacturing process, working through hypothetical scenarios to identify the biggest challenges as we head into the main conference days.
- Gain a practical framework for assessing the need for a new raw material and initiating vendor scouting and evaluation
- Understand key strategies for technical onboarding, including comparability studies, risk assessments, and process validation
- Explore how to integrate new materials into existing regulatory filings and manage global health authority engagement
- Review case studies where early vendor partnerships and cross-functional collaboration enabled successful material transitions in cell and gene therapy pipelines
