蛋白質凝集和最新的分析工具

掌握和克服分析、處方、生產、法規的課題

1月12日∼13日

此部會網羅有關蛋白質凝集的最新傾向和課題，預定舉行有關凝集的機制、凝集的檢出與定量化、特性描述（characterization）工具、可視性及準可視性（只能使用顯微鏡來看）蛋白質凝集的檢出和分析手法、防止蛋白質粒子凝集、凝集對免疫原性和蛋白溶液合理設計的影響等詳細之個案研究和討論。

蛋白質不穩定性的基本原因和現象的掌握

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.

蛋白質凝集和免疫原性

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

因應蛋白質凝集特性描述（characterization）分析法的課題和進步

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