Session 2: CMC Considerations for Personalized mRNA Therapies
2:00 PM – 2:45 PM | West Red Level, Suite 81
CMC Considerations for Personalized mRNA Therapies
This presentation will explore the Chemistry, Manufacturing, and Controls (CMC) considerations unique to the development and production of personalized mRNA therapies. Specifically, attendees will learn:
- Key differences in CMC requirements between personalized mRNA therapies and precision mRNA therapeutics.
- Challenges and strategies in streamlining manufacturing workflows for individualized therapies, including supply chain, rapid turnaround times, facility design, and small-batch production.
This session will provide insight into the complexities of CMC development for personalized mRNA therapies and highlight practical solutions to enable successful clinical implementation.
Speaker:
Jason Gale, Sr. Engineer I, Manufacturing, Moderna
Biography:
Jason is a successful leader with extensive experience in both small and large-scale clinical and commercial manufacturing of recombinant proteins, vaccines, pDNA, and mRNA in multi-product facilities. Expertise includes strategic vision, management (people, matrix, and projects), compliance, Board of Health inspections, complex investigations, continuous improvement, technical transfer, and microbial control.
