Developing a Successful Potency Assay for Complex Biologics

Time: 2:00 pm
day: Day 1 Track 1 AM


• Potency testing is critical to define how effective the product is, consistency of batches and safety

• Share views of regulatory authorities on the potency assay given the recent delays in submissions

• Experience in developing a robust assay to overcome variability when there is a lack of understanding of key attributes or mechanism of action

• Understand what is key to measure, how does analytics intersect with drug development?