Returning for its fourth year, the mRNA Process Development & CMC Summit delivers three days of end-to-end process, CMC, analytical, and regulatory clarity to equip you with the blueprint and peer connections to successfully achieve approvals for your mRNA drug candidates in 2025.
Spanning research, preclinical, IND-enabling, and commercial-stage pipelines, the field continues to tackle urgent process questions across end-to-end production.
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?
Event in Numbers:
125+
Attendees from Large Pharma, Biotech, & Academia
40+
World-Class Speakers
10+
Hours of Dedicated In-Person Networking
25+
Technical Sessions & Case Studies
2
Deep Dive Tracks of Content
Attending Organizations Include:
