Defining Potency Assays for Exosome Therapeutics to Link Mechanism of Action to Measurable Biological Activity & Better Understand Product CQAs
- Establishing potency assays that reflect the proposed mechanism of action, including immunomodulation, angiogenesis or tissue repair
- Moving beyond surrogate markers to functional readouts that capture biologically relevant exosome activity
- Correlating in vitro potency with in vivo efficacy to support clinical translation and dose justification