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Cambridge Healthtech Institute’s 6th Annual

Detection and Characterization of Particulates and Impurities
( 微粒子と不純物の検出と特性評価 )

Hot Topics, Emerging Contaminants and Impurities, Case Studies, and New Technologies

1月21日~22日

Part of the Analytics & Impurities pipeline

Cambridge Healthtech Institute’s 6th Annual Detection and Characterization of Particulates and Impurities conference will bring together leading researchers to discuss hot topics, emerging contaminants and impurities and new characterization tools for impurities that may come from various sources and stages of product development. Through new presentations, informative panel discussions, high-level poster presentations, and interactive breakout discussions, top scientists will share new insights into characterization and control of various impurities. Some of the hot topics for this year will be new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings.

Preliminary Agenda

ASSAY AND TOOLS

Cell-Based FcgR Binding Assay for Sensitive Detection of Biologics Aggregates

Joel F. Cohen-Solal, PhD, Senior Scientist, Global Protein Sciences, AbbVie Bioresearch Center, Inc.

Human IgG1 Hinge Fragmentation as the Result of Radical Mediated Cleavage

Boxu Yan, PhD, Senior Director, Analytical Development and Quality Control, Acceleron Pharma

Comparability Studies for Storage Stability in Single Use Bags

Anil Kumar, PhD, Principle Process Engineer, MSAT, Sanofi Genzyme

PARTICLES AND AGGREGATES

Qualifying a New Method for Submicron Particle Counting and Why It Matters

Gerhard Winter, PhD, Professor, Chair, Pharmaceutical Technology and Biopharmaceutics, LMU Munchen

The Aggregation of Gene Therapy Vectors

Dinen Shah, PhD, Scientist, Biologics Product Development, Allergan

Microfluidic Approaches for the Characterization of Biopharmaceuticals

Paolo Arosio, PhD, Professor, Biochemical Engineering, Department of Chemistry and Applied Biosciences, ETH Zurich

SURFACTANTS

Optimizing Protein-Surfactant Bulk and Interfacial Interactions through Advanced Characterization Techniques for Controlling Aggregation and Viscosity

Samiul Amin, PhD, Associate Professor, Chemical Engineering, Manhattan College

Case Study: Formulation Strategies to Eliminate Polysorbate Degradation Related Particle Formation

Sandy Wang, MSc, Engineer II, Pharmaceutical Development, Genentech



* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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