Webinar

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

• Ashwinkumar Bhirde, PhD. FDA/CDER/OPQ, Senior Pharmaceutical Scientist
• Louise Brogan, PhD, Marketing Director, Yokogawa Fluid Imaging Technologies
• Amber Raines, Ph.D., Senior Director of Client Project Management at Coriolis Pharma, U.S.

Duration: 2 hours, 5 minutes

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.

About the Speakers:

Ashwinkumar Bhirde, PhD
Dr. Ashwinkumar Bhirde is a Senior Pharmaceutical 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.

Louise Brogan, PhD
Louise is a scientist at the intersection of biology, strategy, and communication. With expertise in biochemistry, molecular imaging, and cell biology, she drives the development of flow imaging microscopy applications and method optimization. Known for her innovative approach to problem-solving, she transforms technical insights into concrete actions to ensure success. Louise holds a B.A. in Mathematics and a B.A. in Biochemistry from Colby College, and a Ph.D. in Biochemistry from the University of Notre Dame. Louise has co-authored many peer-reviewed publications that have appeared in journals including Biochemistry, Journal of Clinical Investigation, and Nature. She held a post-doctoral research fellowship at the Jackson Laboratory in Bar Harbor, Maine, and a second fellowship in cardiovascular research at Albany Medical College in Albany, NY. Louise has enjoyed working across industrial, academic, and not-for-profit institutions and brings a proactive mindset to collaboration and partnerships.

Amber Raines, PhD
Amber Raines, Ph.D. is Senior Director of Client Project Management at Coriolis Pharma, U.S., where she leads strategic client partnerships and project execution across biologics development programs. She is an expert at particle characterization and identification of (bio)pharmaceuticals, with a strong scientific background in biophysical characterization, formulation, and analytical development for protein therapeutics. Previously, she served as Senior Director of Rapid Analytics at KBI Biopharma, overseeing biophysical and particle characterization centers of excellence, innovation in analytical technologies, and collaborations with organizations such as NIST, NIH, and AAPS. Dr. Raines has over 15 years of industry experience at companies including Amgen and Merck. She holds a Ph.D. in Chemical and Biological Engineering from the University of Colorado Boulder and is an inventor on a U.S. patent related to reducing immunogenicity in therapeutic proteins.

Submit the form to watch the webinar.