Considerations for mRNA Potency Assay Development for Gene Editing Products
Time: 3:45 pm
day: Day One
Details:
- Overview of matrix approach for potency assay development
- Review of available regulatory guidance and expectations for phased-based approach to potency assay development
- Tools and considerations when measuring biological cascade of mRNA delivery in vitro
- Challenges associated with potency assay development for gene editing products
