Cytiva eBook - 17

WEBINAR

Challenges of host cell protein analysis with ELISA
and how to obtain better coverage of your ELISA antibody reagents

H

ost cell proteins (HCPs) make up a
significant class of process-related
impurities. These impurities must be
reduced to adequately low levels during the
manufacture of biological products to ensure
product purity and patient safety. Due to the
complex composition and low abundance of
HCPs 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 copurifying 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 processor 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
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| GENengnews.com

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 about the overall HCP analytical

control strategy and how to manage risk
through orthogonal characterization.

This event was originally broadcasted
by LabRoots on December 18, 2018.

VIE W IT NOW

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

Dr. Wang 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 HCP ELISAs 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 has specialized in
assay development for monitoring other process residuals such as protease inhibitors, trypsin, MSX, β-glucan, etc. He has authored more than 40 peer-reviewed
scientific publications and presented at many national and international meetings including AAPS's annual meetings, BEBPA's annual conferences (from 2015 to
2018), BPI's conferences 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 David A. Fishman, MD, starting as a postdoctoral researcher in Northwestern
University and later on becoming an assistant professor in New York University
School of Medicine. Dr. Wang received his PhD in cancer pharmacology (microbial
and biochemical pharmaceuticals) from Peking Union Medical College & Chinese
Academy of Medical Sciences in 2002. He also earned a Master's degree in medicine
and a Bachelor's degree in pharmacy.



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Cytiva eBook

Table of Contents for the Digital Edition of Cytiva eBook

Contents
Cytiva eBook - 1
Cytiva eBook - 2
Cytiva eBook - 3
Cytiva eBook - Contents
Cytiva eBook - 5
Cytiva eBook - 6
Cytiva eBook - 7
Cytiva eBook - 8
Cytiva eBook - 9
Cytiva eBook - 10
Cytiva eBook - 11
Cytiva eBook - 12
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Cytiva eBook - 14
Cytiva eBook - 15
Cytiva eBook - 16
Cytiva eBook - 17
Cytiva eBook - 18
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