Developing Analytical & Potency Assays That Connect Product Quality to Biological Function

11:00 am - Friday 19th February 2027

  • Sharing learnings of how preclinical data can link to clinical functionality
  • Exploring how different RNA therapeutics have different assumptions on clinical functionality and how to translate that into assays (e.g. personalised vs gene replacement etc.)
  • Incorporating these considerations early in the preclinical thought process and early-stage clinical development
  • Differentiating mode-of-action assays from simple protein expression readouts: demonstrating clinical relevance

Speakers:

Director CMC
Epitopea Ltd