Particulate matter is a critical quality aspect of biotherapeutics. Control of both visible and subvisible particulate matter remains one of the most persistent and complex challenges in the development and lifecycle management of biologics despite significant advances in analytical and manufacturing controls. This is due to the highly variable properties, the limitations of current analytical tools, and the complexity of distinguishing inherent particulates from particulate contaminants. In this session, the speakers will present emerging knowledge and analytical technologies around different types of visible and subvisible particles. Case studies will be provided on characterization and control of polysorbate hydrolytic degradants, silicon oil, and proteinaceous particles in parenteral drug products. Unique challenges for identification and enumeration of subvisible particulate matter within ophthalmic indication and cell and gene therapy products will also be presented. The insights from presented studies should provide better understanding of respective safety profiles and inform robust risk-based control strategies for particulate matter in biologics.

Session Speakers:

Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Particles in Biopharmaceutical Products

Miguel Saggu, Genentech, a Member of the Roche Group

Controlling Particulate Matter in Ophthalmic Biologics; Establishing a Risk-Based Analytical Approach to Sub-Visible Particulates

Lauren Jones, Regeneron Pharmaceuticals

Visible Particle Control in Biologics and Advanced Therapy Products: Challenges, Case Studies, and Evolving Expectations

Atanas Koulov, Clear Solutions Laboratories AG

Additional Panelists:

Desmond Hunt, USP-US Pharmacopeia

Stanley Kwok, AstraZeneca

Ewa Marszal, CBER, FDA

Sheena Wang, CDER, FDA

Karen Sitney

Appearances