Cambridge Healthtech Institute’s 5th Annual

Host Cell Proteins

Detection, Analysis and Control

August 24-25, 2020

 

Controlling process-related impurities, such as host cell proteins (HCPs), is a critical part of bioprocessing. Analytical methods are available, but coverage and specificity are 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 advanced therapies, biosimilars, in-process testing, and the latest data supporting the link between HCPs and immunogenicity.

Preliminary Agenda

REGULATION AND RISK ASSESSMENT

Host Cell Proteins in the Regulatory Focus

Erika Friedl, PhD, Quality Expert, Hematology and Transfusion Medicine, Paul-Ehrlich-Institute

Managing High-Risk HCPs – Update from BPOG

Fengqiang Wang, PhD, Associate Principal Scientist, Merck

Impact of HCPs on Safety of IV Drugs Administered to the Eye

Francois Huet, PhD, Preclinical Safety Study Monitor & Preclinical Safety Specialist, Senior Investigator I, Novartis

DETECTION AND MANAGEMENT

Analytical Strategy for Individual HCPs that Are Not Detected by Platform HCP Sandwich Immunoassays

Emily Menesale, PhD, Scientist I, Bioassay and Gene Therapy, Analytical Development, Biogen

Making the Right Choice: HCP ELISA Characterization Tools

Feny Gunawan, PhD, Scientist, Department of Analytical Development and Quality Control, Genentech

Monitoring Host Cell Proteins: From an ELISA Assay to a Comprehensive HCP Program

Yiwei Zhao, PhD, Senior Scientist, Analytical Development: Biologics, Takeda Pharmaceuticals

Update from HCP NIIMBL

Abraham M. Lenhoff, Allan P. Colburn Professor, Department of Chemical and Biomolecular Engineering, University of Delaware

Detection of CHO Phospholipase B-Like 2 (PLBL2) in Therapeutic Monoclonal Antibodies

Sheetal Mehta, PhD, Scientist II, Bristol Myers Squibb

Updates on USP Standards for Monitoring Host Cell Protein

Niomi Peckham, PhD, Science and Standards Liaison Officer, Global Biologics, United States Pharmacopeia

How to Deal with Co-Purifying HCP: Analytical Control Strategy, Risk Assessment and Remediation

Séverine Clavier, PhD, Deputy Head, Structural Analysis Laboratory, BioAnalytics Department, Biologics Development France, Sanofi

Host Cell Protein Quantification by Mass Spectroscopy to Support Process Improvements

David L. Narum, Head, Process Development, Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health




For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-247-6266
Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



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