Detecting Particles In Biologic And CGT Drug Products

Particles—both visible and subvisible—can emerge in biologic, gene, and cell therapy products at any point in development and even after approval. Their presence can indicate stability concerns with the active ingredient or problems within the manufacturing process, making accurate particle identification critical for maintaining product quality, safety, and performance.

Learn about the wide spectrum of particle types that can appear, their likely sources, and what they may reveal about the drug product. Analytical tools and characterization strategies are outlined to help distinguish product-related species from process-related or extrinsic contaminants. Gaining clarity on these characteristics supports more effective troubleshooting, risk assessment, and decision-making throughout development.

Early detection of particle issues can uncover root causes, guide process refinements, and reduce downstream challenges that could influence clinical outcomes or regulatory expectations. Key questions scientists should consider when evaluating particle populations are explored, along with examples of how article analysis contributes value across complex therapeutic modalities.