Course Description:
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).Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
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
Who should participate:
- Analytical scientist
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract manufacturing organizations