Advanced Analytical Strategies to Resolve Particle-Driven Instability

Case Study: Particle Instability Unravelled in 8 Days

Particle formation in biologic drug products is one of the most disruptive quality events a development or manufacturing team can face, threatening regulatory compliance, timelines, and patient safety.

Coriolis Pharma’s specialized fast track analytics approach has helped clients identify root causes in as little as 8 days and prevent recurrence.

Access our practical resources below to strengthen your particle identification strategy.

Checklist: 10+ Early Warning Signs of Excipient Degradation

Visible particles can potentially arise at any stage of biopharmaceutical development. From drug product development, process scale-up, during fill-finish and even after market approval.

These particles can negatively impact product safety, efficacy, regulatory compliance, and batch release timelines. Identifying the origin of the particles formation is critical to proactive stability risk management.

Use this checklist to assess whether your current analytical strategy is equipped to detect excipient degradation signals before they become a compliance issue.

Facing Unexpected Particles? Let’s Talk.

Whether you’re troubleshooting an active stability failure or strengthening your monitoring program proactively, our team is ready to help.