About mRNA Proccess Development & CMC Summit
In its fourth year, the mRNA Process Development & CMC Summit once again delivered three days of comprehensive insight into end-to-end process development, CMC strategies, analytical innovation, and regulatory clarity-providing attendees with the blueprint and peer connections needed to drive mRNA drug candidates toward successful approvals in 2025.
Covering programs across research, preclinical, IND-enabling, and commercial-stage pipelines, the summit addressed some of the field’s most pressing process challenges, fostering collaboration and knowledge exchange across the full spectrum of mRNA drug development.
Questions Answered Include:
- How to select the best DNA starting material, from plasmid to synthetic and enzymatic, to improve IVT fidelity and reduce downstream burden?
- What are the most effective in-line analytical tools for controlling dsRNA levels, capping efficiency, and impurity profiles in real time across IVT and purification?
- How do we develop purification strategies that can scale and qualify novel modalities like saRNA and circRNA, without compromising product quality or stability?
- What does regulatory confidence look like at global scale, and how can developers navigate platform comparability, personalized therapies, and process change approvals?
- How can AI-driven predictive formulation models reduce batch failure and improve delivery in vivo, ahead of tech transfer into GMP scale-up?
Attending Companies Include