Subvisible Particle Analysis For End‑To‑End Quality

Subvisible particle quantification is essential for ensuring the safety, efficacy, and consistency of pharmaceutical products. These particles may arise from environmental contamination, manufacturing equipment, or the formulation itself, and can signal risks such as immunogenicity, diminished therapeutic performance, or physical instability. This webinar provides a detailed look at why regulatory authorities require routine monitoring of subvisible particulate matter and how particle analysis supports quality control throughout the entire product lifecycle—from early development to commercial batch release.

A featured case study examines the challenges of developing a precise analytical method for inherent subvisible particles and transferring it from an R&D setting into a GMP‑compliant environment. Attendees will learn about key sources of variability, including sample preparation, equipment performance, operator techniques, and method selection. The session also outlines the documentation, workflow considerations, and validation requirements necessary to ensure accuracy and audit readiness. Overall, the webinar offers practical guidance for improving analytical robustness and maintaining high-quality standards across development and manufacturing.