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 <788>, has been widely adopted across the industry; however, accumulating evidence suggests it may systematically underestimate proteinaceous particulate burden in complex biologics including monoclonal antibodies and insulin formulations and may lack the sensitivity needed to detect subtle manufacturing variability in protein therapeutics.

Flow Imaging (FI) has emerged as a powerful complementary technique, offering not only particle count data but also rich morphological information encompassing particle shape, size distribution, and compositional features that can be critical when characterizing heterogeneous particulate populations such as protein aggregates, silicone oil droplets, and morphologically diverse contaminants.

This webinar will provide a data-driven, case study-based comparison of Light Obscuration and Flow Imaging analytical performance in the context of biologics development and quality assessment. Attendees will gain practical insight into method selection considerations and the scientific rationale for deploying Flow Imaging alongside or as an alternative to Light Obscuration in specific biologic contexts, as well as the product quality implications of method choice including the risk of underdetection and its downstream regulatory and patient safety consequences. The session will also address validation strategy and acceptance criteria development for particulate matter testing in biologic drug products, with an emphasis on fit-for-purpose method design. Professionals working in analytical development, quality assurance, and regulatory affairs will find this webinar relevant, as it aims to share practical perspectives and considerations that may inform particulate matter characterization strategies in biologics programs.

Presented by Ashwinkumar Bhirde, PhD. FDA/CDER/OPQ, Senior Research Scientist

Dr. Ashwinkumar Bhirde is a Senior Research Scientist at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), where he specializes in particulate matter characterization, analytical method development, and Chemistry, Manufacturing, and Controls (CMC) review of biologic drug products. With 15+ years of experience in pharmaceutical product characterization and 12+ years of FDA regulatory science experience, Dr. Bhirde is a nationally and internationally recognized Subject Matter Expert (SME) in particulate matter a critical quality attribute in in injectable biologic drug products. Dr. Bhirde serves as an FDA Liaison to the US Pharmacopeia (USP) Expert Panel for chapters <787>, <788>, and <790>, and actively collaborates with particulate matter experts across CDER, CBER, and CDRH. He has been Session Chair for “Particles in Biologic Drug Products” at IFPAC since 2019 and has served as an invited keynote speaker at international conferences including the APV Workshop in Germany. Dr. Bhirde has authored 34 peer-reviewed publications with over 4,500 citations (h-index: 22), published in high-impact journals including ACS Nano and Nature Scientific Reports, and is a recipient of the 2024 FDA Innovator Award.

Followed by a live question and answers session

Sponsored by Yokogawa Fluid Imaging Technologies Inc

Yokogawa Fluid Imaging Technologies delivers advanced flow imaging microscopy solutions that empower biopharmaceutical teams to confidently characterize subvisible and submicron particles. Our flagship platform, FlowCam, provides rapid, high-resolution images that reveal particle concentration, size distribution, and detailed morphology – critical for discriminating between API aggregates and foreign contaminants. As products advance toward clinical and commercial stages, particle characterization becomes essential for meeting compendial requirements. USP chapters <787>, <788>, and <789> define particulate matter standards for parenteral products, while USP <1788> acknowledges the limitations of these methods and recommends flow imaging microscopy (FIM) as an orthogonal approach. FlowCam’s FIM technology delivers the morphological insight needed to complement light obscuration and membrane microscopy, strengthen risk-based quality decisions, and support regulatory compliance. Now part of Yokogawa Electric, we continue to drive innovation in particle analysis from our headquarters in Scarborough, Maine – helping biopharma teams generate reliable data that accelerates development and ensures product quality.