Analytical approaches and regulatory expectations for characterization and control strategies for subvisible particles in biopharmaceutical products

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00:00:00 Untitled
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00:02:15 Developing safe, effective and consistent drug products requires controls around critical quality attributes
00:03:26 Particle Characterization
00:04:54 Light Obscuration
00:04:59 Increased Expectations for Particle Characterization
00:06:28 Particle Techniques = High Resolution Detection of Degradants
00:09:48 Particle Techniques = High Resolution Detection of Degradants
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00:11:41 Light Obscuration vs MFI
00:12:17 Light Obscuration vs MFI
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00:15:55 Early Evaluation of Particles with Simulated Administration Studies is HIGHLY Recommended!!
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00:25:14 Summary
00:30:43 KBI Particle Characterization Core Facility
00:31:28 Thank you for your
Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products.  With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules.  In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterization of therapeutic products.  Careful interpretation of data and deeper understanding of the method limitations is of utmost importance when using complementary methods to characterize particle profiles of therapeutic products for regulatory submissions. This presentation demonstrates how multiple particle techniques can be used to adequately characterize therapeutic products and their particle populations.