| 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.