Cambridge Healthtech Institute’s 4th Annual

Host Cell Proteins
( 宿主細胞蛋白質 )

Detection, Analysis and Control

2019年8月12-13日


Controlling process-related impurities such as host cell proteins (HCPs) is a critical part of bioprocessing. Analytical methods are available but coverage and specificity is limited. Moreover, the emergence of new techniques, such as mass spectrometry, has further compounded these limitations with regulators now pressing companies for more HCP data.

CHI’s Host Cell Proteins conference brings together industry leaders to discuss critical HCP topics such as: risk assessment and control strategies, HCP characterization, assay coverage, critical reagents and platforming, plus questions relating to biosimilars, in-process testing and the latest data supporting the link between HCPs and immunogenicity.

Preliminary Agenda

LATEST STANDARDS AND REGULATIONS

USP Standards to Support Host Cell Protein Analysis

Diane McCarthy, PhD, Senior Manager, Science and Standards Biologics Pipeline Development, USP

Regulatory News and Views on Host Cell Protein Control

Erika Friedl, PhD, Quality Expert, Paul-Ehrlich-Institute

ANALYTICAL STRATEGIES TO DETECT AND MANAGE HCP

Managing High Risk HCPs

Fengqiang Wang, PhD, Principal Scientist, Merck

Analytical Strategies for HCP

Heather Boux, PhD, Amgen

Orthogonal Methods to Detect, Identify and Quantitate Problematic Host Cell Proteins

Nisha Palackal, PhD, Director, Protein Biochemistry, Regeneron Pharmaceutical, Inc.

Challenges of Implementing HCP Assays for Gene Therapy Programs

Emily Menesale, PhD, Senior Associate Scientist, Analytical Development, Biogen

HCP Assay Development and Optimization for the Quality Control Laboratory

Jeff Schneiderheinze, PhD, Director Bioanalytical Method Development, IOPS, Regeneron

Quantitative Analysis of Host Cell Proteins by LC-MS/MS

Ying Zhang, PhD, Senior Scientist, Analytical Research & Development, Pfizer

Improvements in LC-MS/MS HCP Detection Workflows: More Sensitivity, Better Quantification, and Faster Data Processing

Don Walker, PhD, Pharma Technical Development, Genentech

Confirmation Strategies for HCP Identification and Quantification Obtained by LCMS

Veronika Reisinger, PhD, Lab Head, Biologics Technical Development and Manufacturing, Novartis


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