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Webinar: Challenges of host cell protein analysis with ELISA

Host cell protein (HCP) is a significant class of process-related impurity that needs to be removed to adequately low levels during the manufacturing of biological products to ensure product purity and patient safety. Due to its complex composition and low abundance levels in the final product, sandwich ELISA is often used as the workhorse for HCP testing for its high sensitivity and high throughput. However, the detection and quantitation of HCP by ELISA is highly dependent on the capture and detection antibodies used in the method and their HCP coverage.

The primary challenge for the ELISA method, therefore, is to obtain specific anti-HCP antibody reagents that can potentially capture and detect all HCPs co-purifying with the biological product. Insufficient coverage from the antibody reagents used in ELISA may leave certain residual HCPs undetected in the final product, leading to immunogenecity and other product safety concerns for patients. Therefore, it is critical to generate process-or platform-specific anti-HCP reagents and qualify the reagents to make sure they have good HCP coverage.

In this webinar, we discuss the approaches and steps to obtain reagents with good HCP coverage, from antigen selection for animal immunization, to the use of appropriate methods to determine the reagents’ coverage. We also touch upon the overall HCP analytical control strategy that includes the use of methods orthogonal to ELISA for HCP characterization and analysis.

Learning Objectives:
• Learn the impact of residual HCP to product quality, safety, and efficacy and the importance of HCP analysis.
• Learn the challenges and limitations of HCP ELISA and why the ELISA reagents HCP coverage matters.
• Learn the steps to obtaining reagents with good HCP coverage, starting with antigen selection for animal immunization
• Learn the overall HCP analytical control strategy and risk management through orthogonal characterization.

Fengqiang Wang, PhD
Associate Principal Scientist, Merck & Co.

Fengqiang Wang, Ph.D., is currently an Associate Principal Scientist and Technical Lead in the Biologics Analytical Method Development Group of Merck Research Laboratories (MRL). He started at Merck in 2011 as a senior scientist working on the biochemical characterization of biologics and biosimilar similarity study with originator using a variety of analytical tools such as N-glycan analysis and peptide mapping. Then a major part of his work focused on the development of process-or platform-specific residual host cell protein (HCP) ELISA to support HCP impurity testing in Biologics, including marketed products such as Keytruda and Zinplava. Other than immunoassay development, he also worked on extensive detection and characterization of HCPs and anti-HCP reagents in biologics with 1D/2D SDS-PAGE, 2D-DIGE, 1D/2D-Western blot and 1D/2D-LC-MS. In addition, he is also specialized in assay development for monitoring other process residuals such as protease inhibitors, trypsin, MSX, β-glucan etc. He has authored more than40 peer-reviewed scientific publications and presented at many national and international meetings including AAPS annual meeting, BEBPA HCP Annual Conferences from 2015 to 2018, BPI, and CHI's Bioprocessing Summit HCP Conference from 2016 to 2017. He also authored several book chapters on antibody engineering and ovarian cancer and had two patents on antibody drug conjugates.

Before Joining Merck, Dr. Wang had devoted almost a decade of his career in ovarian cancer research in the National Ovarian Cancer Early Detection Program run by Dr. David A. Fishman, starting as a post-doctoral researcher in Northwestern University and later on becoming an Assistant Professor in New York University School of Medicine. Dr. Wang received his Ph.D. in Cancer Pharmacology(Microbial and Biochemical Pharmaceuticals) from Peking Union Medical College & Chinese Academy of Medical Sciences in 2002 and had a Master degree in Medicine and Bachelor degree in Pharmacy.