Examining Analytical Requirements for Lipid Nanoparticle Formulations for CRISPR Delivery
Time: 2:00 pm - 4:00 pm
day: Pre-Conference Workshop Day
Details:
- Highlighting the main formulations of lipid nanoparticles (LNPs) used for CRISPR delivery in mRNA, plasmid, and RNP forms
- How does LNP decoration impact biodistribution and analytical strategy?
- Effectively characterizing cargo, including guide-mRNA ratios and degradation levels
- How to account for inherent variability in LNP variability when designing assays to measure efficacy
- Developing CQAs and phase requirements for product development and manufacture
- Understanding the key regulatory requirements for DS and DP analytical testing, including potency strategy to demonstrate LNP functional activity
