Cambridge Healthtech Institute’s Second Annual

Detection, Characterization and Control of Impurities in Biologics
( 生物製劑中的雜質 )

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

2019年8月15-16日


CHI's 2nd Annual Detection, Characterization and Control of Impurities in Biologics conference will bring together leading experts 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

REGULATIONS AND GUIDELINES

USP Standards for Monitoring Product-Specific and Process-Specific Impurities in Biologics

Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

Aseptic Processing Challenges For Biologics

Jen Juneau, Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

MANAGING IMPURITIES IN CELL AND GENE THERAPY PRODUCTS

Analytical Strategies for Characterizing Residuals in Autologous Chimeric Antigen Receptor (CAR) T-Cell Therapy

Hai Yue, PhD, Senior Scientist, Analytical Development, Juno Therapeutics, A Celgene Company

Managing Impurities in AAV-based Gene Therapy Products

Mark Plavsic, PhD, Chief Technology Officer and Head of Nonclinical Development, Lysogene

PRODUCT AND FORMULATION IMPURITIES

Molecular Interactions Between Drug Product Formulation Excipients and Infusion Containers

Kashmira Dilrukshan, Associate Research Scientist, Drug Product Science Technology, Bristol-Myers Squibb

Factors Influencing Polysorbate's Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Wendelin Kranz, MSc, Scientist LC-MS, Coriolis Pharma Research GmbH

PROCESS IMPURITIES

Understanding Polysorbate Degradation Due to Process Impurities: Rates and Mechanisms and Their Impact on Stability

Christopher O’Brien, PhD, Process Engineer III, Process Science, Sanofi

Host Cell Protein Characterization by LCMS

Guifeng Jiang, PhD, Senior Manager, Analytical Science, Boehringer-Ingelheim, USA

Generating Data to Support the Understanding of Manufacturability of Monoclonal Antibodies

Michael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Centre for Process Innovation Ltd., National Biologics Manufacturing Centre


* 活動內容有可能不事先告知作更動及調整。