- 凝集和粒子 -
The phenomenon of protein aggregation has perplexed many scientists. All mechanisms of aggregation are not conclusively known, while sources of aggregation continue to surface. Regulatory authorities put great emphasis on the identification and characterisation of these aggregates, particles and impurities due to their implications on product safety, efficacy and immunogenicity risks; thus, companies are constantly on the lookout for better and more robust ways to detect and mitigate these aggregates.

PEGS Europe’s 5th Annual Protein Aggregates & Particles brings the latest understanding on mechanisms and sources of aggregation, strategies to mitigate aggregation during engineering and process development, as well as technologies and approaches to characterise and control these impurities.


Preliminary Agenda

MECHANISMS OF AND IMPLICATIONS FOR PARTICLE FORMATION

KEYNOTE PRESENTATION: Protein Gelation at Interfaces: Implications for Aggregation and Particle Formation
Theodore W. Randolph, PhD, Kenneth and Genevieve Gillespie Professor, Department of Chemical and Biological Engineering, University of Colorado

Weak, Promiscuous IgG Self- and Hetero-Association: Implications for Aggregation and Viscosity
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

Factors Influencing Biotherapeutic mAb Aggregation
Linda Yi, PhD, Senior Scientist, Analytical Development, Biogen

PREDICTIONS OF AGGREGATION PROPENSITY

Using Chemical Denaturants to Improve Predictions of Biopharmaceutical Aggregation during Storage
Robin Curtis, PhD, Senior Lecturer, Chemical Engineering and Analytical Science, University of Manchester

Prediction of Aggregation Propensity at Early Development Stage Using Orthogonal Characterization Methods
Joël Richard, PhD, Senior Vice President, Pharmaceutical Development – Peptides, R&D, Ipsen

AGGREGATION ASSESSMENT, QUANTIFICATION AND CONTROL

Regulatory Considerations for Impurity Characterization and Control for Biological Products
Audrey Jia, PhD, Principal Consultant, CMC, DataRevive LLC

Assessing and Addressing Biopharmaceutical Aggregation
David Brockwell, PhD, Associate Professor, School of Molecular and Cellular Biology, University of Leeds

Scale-Down Models for Freezing/Thawing Process to Control Aggregation
Karoline Bechtold-Peters, PhD, Senior Strategy and Technology Leader, Biologics Technical Development & Manufacturing, Novartis Pharma AG

Capreomycin Inhibits the Initiation of Amyloid Fibrillation and Suppresses Amyloid Induced Cell Toxicity
Rizwan Khan, PhD, Professor, Interdisciplinary Biotechnology Unit, Aligarh Muslim University

A New Alternative to Conventional Aggregate Quantitation and Sizing
Oliver Bannach, PhD, CEO, Attyloid GmbH

STABIITY AND VISCOSITY DETERMINATION FOR AGGREGATION CONTROL AND FORMULATION DEVELOPMENT

Stability of Protein Disulfides: Sensitive Targets for Oxidation and Light-Induced Degradation
Christian Schoneich, PhD, Professor, Pharmaceutical Chemistry, University of Kansas

Using Physics-Based Simulations to Understand the Determinants of Viscosity in Concentrated Antibody Solutions
Benjamin Walters, PhD, Scientist, Pharmaceutical Development, Genentech, Inc.

Quantification and Degradation Monitoring of PS80 in One Single Analysis Using QDa Mass Detector
Pierre Guibal, PhD, Analytical Scientist, Sanofi France

Protein-Excipient Interactions Evaluated via NMR Studies in Polysorbate-Based Multi-Dose Protein Formulations: Influence on Antimicrobial Efficacy and Potential Study Approach
Riccardo Torosantucci, PhD, Lab Head, Formulation Development, Pharmaceutical Development Biologics, Sanofi-Aventis Deutschland GmbH


* 活动内容有可能不事先告知作更动及调整。

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