This annual meeting covers the latest trends and challenges in protein aggregation. It features in-depth case studies and interactive discussions on mechanisms of aggregation, detection and quantitation of aggregates, characterization tools, visible and sub-visible protein aggregation detection and analysis techniques, prevention of particles, impact of aggregation on immunogenicity and rational design of protein solutions.
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THURSDAY, JANUARY 12
1:00 pm Conference Registration
1:45 Chairperson’s Remarks
Wim Jiskoot, Ph.D., Professor, Drug Delivery Technology, Leiden University
» KEYNOTE PRESENTATION
1:50 Surface Charge Distribution and its Potential Impact on Protein-Protein Interactions and Viscosity at High Protein Concentrations
Steve Shire, Ph.D., Staff Scientist & Group Leader, Late Stage Pharmaceutical Development, Genentech
Many properties of proteins including solubility, self-association, conformation etc. are mediated by electrostatic interactions. Often these interactions are discussed in context of the isoelectric point and “continuous” charge distribution models. However, because of this oversimplification, the consequences of actual charge distribution on physical properties cannot be determined. In the case of highly concentrated protein solutions, this problem is exacerbated, as will be shown by poor correlation of physical properties such as viscosity with the net charge of the protein.
2:35 Associative Phenomena in Protein Solutions: Role of Protein Salt Ion Interactions
Atul Saluja, Ph.D., Research Investigator, Aseptic Technology, Bristol-Myers Squibb
Interactions between protein molecules and salt ions are common in physiological and pharmaceutical solutions, although the mechanisms and consequences are less well understood. From a pharmaceutical perspective, understanding protein salt ion interactions is critical since ionic excipients are routinely employed as buffers, tonicity modifiers, stabilizers, etc. in protein formulations. Here, case studies are presented highlighting the role of ions in modulating the associative phenomena critical to protein formulation development, i.e. aggregation, precipitation and self-association.
3:05 Emerging Techniques for Monitoring Viscosity of Protein Formulations
Kevin Mattison, Ph.D., Principal Scientist, Bioanalytics, Malvern Instruments
3:35 Networking Refreshment Break in the Exhibit Hall with Poster Viewing
4:30 Mitigation of Crystallization-Induced mAb Dimer Formation in Cold Storage by Modulating Solution Composition
Dan Zarraga, Ph.D., Scientist, Late Stage Pharmaceutical Development (LSPD), Genentech
5:00 High Concentration Formulation Development at Integrity Bio, Inc.
Byeong Chang, Ph.D., President, Integrity Bio, Inc.
Experimental approaches and novel formulations made of approved excipients to address common issues observed at higher concentration of proteins or antibodies, including precipitation, aggregation, and/or high viscosity, have been developed to achieve high concentration drug products. The combinatorial approach can be applied to present antibody therapeutics in the market-competitive form of prefilled syringes.
5:15 Sponsored Presentation (Opportunity Available)
5:30 The Mechanism of Self-Association in a Human Monoclonal Antibody
Yiqing Feng, Ph.D., Associate Director, Biologics Research, Biotechnology Center of Excellence, Janssen Research & Development, LLC
We have identified an aggregation hot spot in a human monoclonal antibody. From a series of mutagenesis and biophysical studies we found evidence to support the hypothesis that tetramer formation of the Fab fragment led to an extensive network of mAb due to the bivalency of the mAb and eventually precipitation. Our findings highlight the difficulty with antibody engineering when paratope and aggregation hot spot overlap, and suggest that identifying the aggregation hot spot early will enable more effective engineering strategies.
6:00 Close of Day
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Links to Companion Meetings
Lyophilization and Emerging Drying Technologies
Optimizing Biologics Formulation Development
Higher Throughput Protein Purification
Protein Aggregation and Emerging Analytical Tools