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 seasoned biopharmaceutical professional with over 20 years of experience spanning process development, quality control, and manufacturing sciences, with a focus on microbial and mammalian systems. Currently a Senior Engineer I at Moderna, Jason leads technology transfer initiatives supporting individualized neoantigen mRNA therapies. Prior to Moderna, he spent over two decades at Pfizer, where he led microbial control strategies, contamination prevention, and facility modernization across clinical and commercial programs. Jason currently serves on the Board of Directors for the National Ataxia Foundation, helping guide strategic direction and advocacy efforts. He holds a B.S. in Biotechnology from Rutgers University and is a Certified Pharmaceutical Industry Professional (CPIP).
