The Fundamentals of Developing mRNA-Based Therapeutics
Regulatory Stages of mRNA-Lipid Nanoparticle Drug Development
Each regulatory phase of mRNA therapeutic development consists of specific goals, steps and end points. There are also some unique challenges and risks in each stage of the drug development process. Learn the fundamentals of developing mRNA-lipid nanoparticle (LNP) drug products from discovery through to commercialization, including:
- How to plan a product development strategy specific for mRNA-based therapeutics
- Studies and methodologies to select a lead mRNA-LNP drug candidate and ensure formulation scalability
- Key end-of-stage criteria for market approval, including assays and analytical methods
- Regulatory documentation required for clinical development and commercial production
Read the full whitepaper here.