Considerations for mRNA Potency Assay Development for Gene Editing Products

Time: 3:45 pm
day: Day One


  • 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