(NEW DATA) Designing a Potency Assay for a Product with a Complex or Unknown Mechanism of Action to Mimic In Vivo Function & Satisfy Regulators

Time: 9:30 am
day: Day 2


  • Brainstorming approaches for developing a functional potency assay for proteins with a complicated or unknown function in vivo
  • How many protein read-outs are necessary for products undergoing posttranslational modifications or other structural changes?
  • Determining the stage of development from which multiple protein assays are required to anticipate and overcome the regulatory challenge