タンパク質凝集と最新の解析ツール

解析、処方、生産、規制にまつわる課題の把握と克服

1月12日〜13日

この部会は、タンパク質凝集にまつわる最新のトレンドと課題を網羅するもので、凝集のメカニズム、凝集の検出と定量化、キャラクタリゼーションツール、可視性および準可視性（顕微鏡でしか見ることができない）タンパク質凝集の検出と分析のための手法、タンパク質粒子凝集の防止、免疫原性とタンパク溶液の合理的な設計に対する凝集の影響などに関する詳細なケーススタディや討論が予定されています。

タンパク質不安定性の基本的な原因と現象の把握

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.

タンパク質凝集と免疫原性

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

タンパク質凝集のキャラクタリゼーションに対応する解析法の課題と進歩

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