LNP Summit 2025: Regulatory Considerations for Novel Lipids
Presented at our LNP Summit Boston – Sept 9, 2025
by Dr. Jason Coleman, Associate Director, Lipids & LNPs Platform, CordenPharma
In this session, CordenPharma’s Lipids & LNPs Platform Director, Dr. Jason Coleman, provides a clear and practical overview of the regulatory expectations surrounding novel lipids used in LNP formulations, essential guidance for anyone planning to take an ionizable lipid into clinical development. His talk outlines:
🔹 What qualifies as a novel lipid from a regulatory perspective
🔹 Key CMC requirements to consider early in development
🔹 Critical supplier expectations for producing clinical‑scale novel lipids
🔹 How the regulatory pathway impacts formulation and manufacturing strategy
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