Cambridge Healthtech Institute’s 3rd Annual

Host Cell Proteins

Detection, Analysis and Control

August 13-14, 2018

A critical part of bioprocessing is the control of process-related impurities such as host cell proteins (HCPs), which co-purify with the drug substance and can cause adverse effects such as immunogenicity. Analytical methods are available but coverage and specificity is limited. Moreover, the emergence of new expression systems, new products and 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


New USP Initiatives to Support Host Cell Protein Analytical Methods

Maura Kibby, PhD, Director, Science & Standards, Global Biologics - ‎U.S. Pharmacopeia


Risk Assessment of HCPs

Denise Krawitz, PhD, Principal Consultant, CMC Paradigms LLC

Evaluation of Analytical Technology to Accelerate Process Development and Support Next-Generation Manufacturing

Caitlin Kramer, PhD, Associate Scientist, Process Development Analytics, Bristol-Myers Squibb

HCP Assay Strategy for Gene Therapy Programs

Elise Levi, Associate Scientist III, Analytical Development, Biogen

Determination of Proteins Detected by Host Cell Protein ELISA Assays Using Mass Spectrometry

Michelle Busch, PhD, Scientist, Sanofi US

Advances in HCP Analysis for the Quality Control Laboratory

Jeffrey Schneiderheinze, PhD, Associate Director, Biochemistry Method Development, Regeneron Pharmaceuticals, Inc.

Same but Different: A Case Study of HCP Comparability for an In-Licensed Project

Feny Gunawan, PhD, Scientist, Analytical Operations, Genentech

The Impact of HCPs on Process Development

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

For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute
Phone: 781-247-6266

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359

Companies L-Z

Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412


Premier Sponsors:

Millipore Sigma

Unchained Labs