蛋白质凝集和最新的分析工具

掌握和克服分析、处方、生产、法规的课题

1月12日～13日

此部会网罗有关蛋白质凝集的最新倾向和课题，预定举行有关凝集的机制、凝集的检出与定量化、特性描述（characterization）工具、可视性及准可视性（只能使用显微镜来看）蛋白质凝集的检出和分析手法、防止蛋白质粒子凝集、凝集对免疫原性和蛋白溶液合理设计的影响等详细之个案研究和讨论。

蛋白质不稳定性的基本原因和现象的掌握

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, Inc.

Associative Phenomena in Protein Solutions: Role of Protein Salt Ion Interactions

Atul Saluja, Ph.D., Research Investigator, Aseptic Technology, Bristol-Myers Squibb

The Importance of Protein Surface Charge on Biological Activity, Inherent Structural Stability, and Formulation Shelf Life

Kevin Mattison, Ph.D., Principal Scientist, Bioanalytics, Malvern Instruments (tentative)

The Mechanism of Self-Association in a Human Monoclonal Antibody

Yiqing Feng, Ph.D., Associate Director, Biologics Research, Biotechnology Center of Excellence, Centocor R&D, Inc.

蛋白质凝集和免疫原性

The Regulatory Challenges of Protein Aggregation

Jack Ragheb, Ph.D., Senior Regulatory Research Officer and Principal Investigator, Division of Therapeutic Proteins, FDA

Protein Aggregation and the Immune System: Friend or Enemy? In vivo Models to Investigate Impact of Protein Aggregates on Formation of Anti-Drug Antibodies

Melody Sauerborn, Ph.D., Pharmaceutics, University of Utrecht; CEO, ADA InVivo BV

因应蛋白质凝集特性描述（characterization）分析法的课题和进步

Aggregates and Their Analysis: Some Perspectives and Lessons from Working with 100+ Products

John Philo, Ph.D., Vice President, Director of Biophysical Chemistry, Alliance Protein Laboratories

Addressing New Analytical Challenges in Protein Formulation Development

Darryl Davis, Ph.D., Principal Research Scientist, Innovation and Technology Lead, Analytical Development and Large Molecule Analytical Development, Johnson & Johnson

Characterization of Submicron Particle Distributions in Biologics Formulations

Flaviu Gruia, Ph.D., Scientist, Analytical Biochemistry, MedImmune

Characterization of Sub-Visible Particles in Therapeutic Protein Formulations

Tobias Frommknecht, Formulation Scientist, pRED, F. Hoffmann-La Roche Ltd