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단백질 응집과 최신 해석툴 해석, 처방, 생산, 규제에 관련된 과제의 파악과 극복1월 12일∼13일 이 부회는 단백질 응집에 관련된 최신 동향과 과제를 다루며, 응집의 메커니즘, 검출과 정량화, 캐릭터리제이션툴, 가시적 및 준가시적(현미경으로만 볼 수 있음) 단백질 응집의 검출과 분석을 위한 방법, 단백질 입자 응집의 방지, 면역원성과 단백 용액의 합리적인 설계에 대한 응집의 영향 등에 관한 상세한 사례연구 및 토론이 예정되어 있습니다. 단백질 불안정성의 기본적인 원인과 현상 파악 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.
단백질 응집과 면역원성 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
단백질 응집의 캐릭터리제이션에 대한 해석법의 과제 및 진보 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 |
