Analysis of subvisible and visible particles—including foreign particles, protein aggregates from the API in biologics, microbubbles, and silicon oil droplets—is required as part of lot release. Recent years have seen advances in analysis technology, as well as studies to understand and assess biological consequences of these particles. Characterization of aggregates/particles should be part of product characterization during development, resulting in an understanding of what is normal for a product.

This webcast will explore the analytical methods available for particles/aggregates ranging in size from submicron to visible particles, with emphasis on the subvisible particles (1–100 µm).

Topics for discussion include:
– A brief overview of the historical safety concerns
– The current state of analysis across the industry
– A discussion of a phase-appropriate, risk-based approach

Subject area:
Biologics

Objectives (If applicable):
n/a

Target Audience (If applicable):
Analytical scientist
QA/QC analysts
R&D scientists, managers
Manufacturing scientists, managers
Regulatory affairs specialists
Contract manufacturing organizations