Where Biologic Stability Programs Fail—and How ICH Q1 Can Help You Get It Right (Free Webinar)

The draft ICH Q1 guidance marks a major shift in biologics stability, turning it from a back-end regulatory task into a front-line, risk-based development discipline. This session explores why traditional approaches fall short, where hidden risks emerge late, and how ICH Q1 can be applied to strengthen programs across the product lifecycle.

You’ll learn how to:
– Identify common stability program failures that surface during INDs, comparability, and scale-up
– Apply ICH Q1 principles to real-world storage, excursion studies, and forced degradation
– Reduce late-stage regulatory, analytical, and supply-chain risk
– Build stability strategies that support confident IND, BLA, and commercial execution