Webinar

Optimizing Biologic Formulations Through Subvisible Particle Characterization: Insights from Flow Imaging Microscopy

Presented by AAPS

Speaker: Tyler Carter, PhD, Senior Applications Scientist, Yokogawa Fluid Imaging Technologies

Duration: 60 minutes

Formulation development is a cornerstone of successful biotherapeutic design, directly influencing product stability, safety, and clinical performance. Among the critical quality attributes (CQAs) that must be rigorously monitored, insoluble proteinaceous subvisible particulates (SVPs) present a unique challenge due to their potential to compromise efficacy and trigger immunogenic responses.

This AAPS eLearning webinar explores the scientific and regulatory importance of SVP characterization in biologics and highlights how formulation strategies can mitigate particulate formation. Central to this discussion is flow imaging microscopy (FIM), a powerful analytical technique that provides real-time, high-resolution visualization and quantification of SVPs.

You will gain insight into how FIM offers unmatched capabilities in particle morphology analysis, enabling researchers to distinguish between intrinsic, extrinsic, and inherent particles. The session compares FIM with traditional orthogonal and complementary methods such as light obscuration, membrane microscopy, and light scattering techniques, illustrating why FIM is indispensable for formulation scientists seeking to optimize product quality and meet regulatory expectations. This webinar is ideal for professionals in formulation development, analytical sciences, and quality control who are focused on advancing the stability and safety of biologic drug products.

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