Applying complementary particle techniques for assessing comparability and biosimilarity of therapeutic products

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00:00:00 Welcome
00:00:15 Introduction
00:01:27 Particles: Complementary Technologies for Characterization and Identification
00:01:37 Protein Particle Characterization
00:02:14 Protein Particle Characterization
00:02:19 The Particle Profile
00:03:23 Many Factors Impact Particle Profiles
00:06:02 Particle Characterization
00:06:59 KBI Particle Techniques
00:08:02 Untitled
00:08:31 Case Study 1 – Neupogen and Zarxio
00:09:10 MFI Analysis
00:09:47 MFI Analysis - Images
00:10:20 Untitled
00:10:58 Resonant Mass Measurement (Archimedes)
00:12:27 Archimedes
00:12:42 Archimedes – Silicone oil vs not
00:13:28 Nanosight
00:14:35 Non-silicone Oil Particles
00:15:01 Morphologi G3-ID
00:15:38 Morphologi G3-ID -Zarxio
00:16:35 Morphologi G3-ID - Neupogen
00:17:05 DLS – Raman (Helix)
00:18:14 DLS-Raman (Helix)
00:18:37 DLS-Raman (Helix)
00:19:32 Summary of Biosimilarity Studies
00:20:18 Untitled
00:20:40 Factor VIII - Recombinate
00:21:05 Particles Delivered with Factor VIII Products
00:22:13 The Importance of Characterizing Product Post Infusion
00:23:04 Systems used in Recombinate Study
00:23:22 Microparticles in IV Infusion of Recombinate
00:23:57 Minimal Effects of Filters on Nanoparticles
00:24:18 RMM: oil droplets and non-silicone oil particles
00:24:58 SEC-MALLS: Catheter without filter sample
00:25:28 Summary and Recommendations for IV/Device Compatibility Studies
00:26:49 Untitled
00:27:00 Application of Morphologi G3-ID for Particle Characterization of a Topical Product
00:27:29 Morphologi G3-ID
00:28:04 Typical Lot Release Data
00:28:43 Morphologi G3-ID Analysis Takes You a Step Further
00:29:18 Imaging vs. Laser Diffraction
00:29:33 Regional Single Particle Spectra
00:29:43 Raman-Derived API Size Distributions
00:30:04 Results
00:30:09 Particle Characterization in lieu of Clinical Endpoint BE Studies
00:31:32 Summary
00:33:33 Acknowledgments
00:34:06 Questions?
00:34:14 Contact Information

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. Careful interpretation of data and in-depth understanding of the method limitations is of utmost importance for using complementary methods to characterize particle profiles. 

This presentation demonstrates how multiple particle techniques can be used to characterize therapeutic products and their particle populations. We provide case studies to highlight the advantages of particle methods for characterizing comparability and biosimilarity.