Webinar

Addressing Subvisible Silicone Oil Droplets

Industry Challenges, Analytical Strategies, and USP’s Rationale for a New General Informational Chapter

Speakers:
Desmond G Hunt, Senior Principal Scientist, US Pharmacopeia
Laura A. Philips, PhD, MBA, President and Chief Executive Officer, Spheryx, Inc.
Tyler Carter, PhD, Senior Application Scientist, Yokogawa Fluid Imaging

Duration: 121 minutes

This webinar explores the critical challenges of subvisible silicone oil droplets (SiOPs) in biopharmaceuticals, particularly in prefilled syringes and autoinjectors. Experts discuss the analytical limitations of traditional methods like light obscuration and present advanced strategies—including flow imaging microscopy, holographic microscopy, and AI analysis—to differentiate silicone oil from protein aggregates.

Attendees will also gain insight into the USP’s rationale for a new general informational chapter and learn risk-based frameworks for lifecycle control and regulatory compliance.

Key Topics Covered:

• Industry Context: The impact of SiOPs on evolving delivery systems.
• Analytical Strategies: Comparing compendial methods with emerging orthogonal tools.
• Safety & Immunogenicity: Evaluating clinical risks and protein-silicone interactions.
• Regulatory Rationale: USP’s development of a new informational chapter for SiOPs.
• Control Strategies: Best practices for siliconization, formulation, and manufacturing.

Fill out the form on this page to view the recorded webinar on-demand.