Silicone oil-induced protein aggregation and immunogenicity

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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.