| 00:00:00 | Welcome! |
| 00:00:45 | Silicone Oil-Induced Protein Aggregation and Immunogenicity |
| 00:01:02 | Acknowledgments |
| 00:01:11 | Adverse Immunogenicity: When Miracle Drugs Fail |
| 00:01:16 | Immunogenicity: Particles as Adjuvants |
| 00:01:46 | Protein Interactions with Silicone Oil: Example of Container/Closure Incompatibility with Protein |
| 00:02:57 | Agitation with Silicone Oil Microdroplets Accelerates IgG Aggregation |
| 00:04:16 | Adsorption to Silicone Oil Reduced by Polysorbate |
| 00:05:15 | Adsorption to Silicone Oil can Perturb IgG Tertiary Structure |
| 00:05:52 | Untitled |
| 00:06:34 | Particle analysis in presence of silicone oil |
| 00:08:03 | Particles as Adjuvants: Interferon-b Products |
| 00:08:28 | Neutralizing Antibody (NAb): Summary of Clinical Data for IFN-b Products |
| 00:08:53 | Dosage Form/Formulation of Ifn-β Products Tested |
| 00:09:26 | Particle Counts by Microflow Imaging (>1µm) |
| 00:09:59 | Particle Counts by Microflow Imaging (>1µm) |
| 00:10:12 | Particle Morphology |
| 00:10:35 | Archimedes for Particles in IFN-b in Syringes |
| 00:12:17 | Why do subvisible protein particles so often look like these? |
| 00:13:41 | Causes of Protein Particles: Interfaces |
| 00:15:18 | Gelation of a mAb at silicone oil-water interface |
| 00:16:26 | Experimental setup for gel rupture at the silicone oil-water interface |
| 00:16:56 | Gel rupture leads to loss of soluble protein |
| 00:17:22 | Presence of surfactants resulted in reduced aggregation |
| 00:18:21 | Presence of surfactants led to a decrease in the protein particle mass detected by Archimedes |
| 00:19:58 | Untitled |
| 00:20:53 | Silicone Oil-Induced Protein Aggregation |
| 00:21:51 | Alternative to siliconized syringes |
| 00:22:17 | Untitled |
| 00:23:16 | Untitled |
| 00:23:21 | Untitled |
| 00:24:56 | Untitled |
| 00:26:13 | Immunogenicity of mGH Adsorbed to Silicone Oil Droplets in Emulsion (SOE) |
| 00:27:19 | Conclusions |
| 00:28:21 | 2016 Workshop on Protein Aggregation and Immunogenicity |
| 00:29:10 | Thank you for your attentionAny questions? |
| 00:35:06 | Contact Information |
Prefilled syringes are often used for packaging and delivery of therapeutic proteins. But the silicone oil lubricant can cause protein aggregation and promote adverse immunogenicity. In this presentation, data on these two topics will be summarized. In addition, the mechanism for silicone oil-induced protein aggregation will described, and formulation approaches to mitigate protein aggregation will be highlighted. Finally, the problems of analyzing samples that contain both protein particles and silicone oil droplets, and the solutions to these problems afforded by the unique data available from the Archimedes instrument, will be addressed.