(CASE STUDY) (NEW DATA) A Potency Assay Development Process – Comparing Analytical Tools to Determine HPLC as the Preferred Readout Method

Time: 2:00 pm
day: Day 2

Details:

  • Comparing HPLC with various other options such as luciferase reporter, enzyme activity, and LC-MS assays
  • Levering HPLC to define a robust MOA potency assay strategy suitable for commercialization
  • How does an HPLC approach align with the new FDA potency guidance? 

Speakers: