As the regulatory and scientific landscape evolves, the stability of well-characterized biological products remains a cornerstone of product quality, patient safety, and global access. This plenary session, What's New in the World of Stability: Navigating the New ICH Q1 Landscape, explores the latest developments and forward-looking strategies in stability science, with a focus on the emerging expectations surrounding ICH Q1 revisions and their implications for biologicals.

Key aspects of the draft revision to the ICH Q1 guideline include streamlining the existing stability series (ICH Q1A-F and Q5C) into a single guideline, promoting a harmonized interpretation by addressing identified gaps and ambiguities, strengthening the application of risk management with innovative tools and strategies, introducing new topics and considerations for advanced therapies. The main goal of these revisions was to provide modernized guidance for a standard/traditional approach to stability while also providing details on the familiar refrain ‘alternative risk-based approaches were scientifically justified’.

This session will look to develop an understanding of the revised guideline and its potential application when finalized. An overview of the guideline, highlighting core, revised, and new content will provide an awareness of the overall document while highlighting the goals of the revision. A regulator’s perspective on the guideline will provide an overview of the risk-based approaches included in the guideline while identifying what is being considered to support regulatory-readiness ahead of implementation of the guideline.

Finally, the session will address the opportunity and challenge of enabling these innovations across international markets, focusing on the role of primary stability studies in generating product knowledge and establishing a scientifically justified shelf-life. Through case studies and global perspectives, participants will leave with a deeper understanding of how to harmonize stability strategies with evolving expectations, while maintaining scientific integrity and regulatory standards.

Session Speakers:

ICH Q1 Stability Guideline Revision- What's New?

Linda Lemieux, Merck & Co., Inc.

Predictive Stability for Biopharmaceuticals: Accelerating Patient Access through Industry Recommendations and Stakeholder Alignment

Daniel Skomski, Merck & Co., Inc. and Andrea Ji, Genentech, a Member of the Roche Group

ICH Q1 Guideline Revisions: Risk Frameworks and Regulatory Readiness

Paula Russell, Health Canada

Additional Panelists:

Ashutosh Rao, CDER, FDA

Adam Rauk, Eli Lilly and Company

Andrea Ji

Staff Scientist, Genentech, A Member of the Roche Group

Appearances