Navigating Particulate Matter Analysis in Biologic Drug Products: A Critical Evaluation of Flow Imaging and Light Obscuration for Product Quality Assessment

Particulate matter control is a cornerstone of biologic drug product quality, yet the analytical methods used to characterize it are not without limitations. Light Obscuration (LO), the compendial standard under USP , has been widely adopted across the industry; however, accumulating evidence suggests it may systematically underestimate proteinaceous particulate burden in complex biologics including monoclonal.

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