Cytiva eBook - 3

Better coverage assays for better HCP ELISAs:
Quantitating the benefits
By Gareth John Macdonald

B

iotechnology has turned cells into machines capable of making biological medicines that are more effective and better targeted than traditional drugs. But
manufacturing biopharmaceuticals in a living system is difficult. As well as the
desired molecule, the cell lines used in production also make their own proteins, which
they need to grow, divide, and survive.

This is a problem because these host cell proteins (HCPs) can impact the product. For
example, enzymatically active HCPs can degrade therapeutic proteins, thereby lowering yields. More important, some HCPs can pass through processing steps and end
up in the finished product. These HCPs represent a major challenge because they are
associated with increased risk of immunogenicity.1
As a result, drug firms must make efforts to first quantify and then remove HCPs from
processes to minimize their presence in finished products. ELISAs are used to quantify
HCPs. However, even the best assay cannot recognize all cellular proteins. So, firms
must assess ELISA coverage before determining what downstream removal steps are
needed. This article will look at innovations in HCP ELISA coverage assays that have the
potential to streamline testing and accelerate process development.
HCP quantitation
"HCPs are regarded as a process-related impurity in the production of biologics,"
states Joe Hirano, Program Manager at Cytiva. "Even if significant efforts to remove HCPs
are made, biologics may contain a small amount of HCP in the final product."
"A reason for this difficulty," notes Hirano, is that "quantitative measurement has been a
challenge. So far, we do not have a specific and sensitive enough method to detect all
traces of HCPs in drug products."
"To develop better removal methods," he insists, "we need better measurement
methods that are more specific and more sensitive."
3

| GENengnews.com

ELISA and coverage kits for

end-to-end HCP monitoring capabilities
Amersham™ HCPQuant CHO kit is a generic ELISA kit for detecting host
cell protein impurities in drug samples produced in CHO cell lysate, and
the new Amersham HCP DIBE™ CHO kit for validating HCP ELISA.
Amersham HCPQuant CHO cell lysate kit, designed by Rockland Immunochemicals, Inc. to detect a wide range of CHO HCP impurities, raises
the bar for HCP ELISA assay kits. The combination of high coverage (89%)
with a broad linear range (2-200 ng/mL) increases the confidence of HCP
quantification in both the low- and high-molecular weight ranges, which
is critical to managing the risk of increased immunogenicity arising from
HCP in process-derived samples.
Amersham HCP DIBE CHO kit measures antibody coverage of the Amersham HCPQuant CHO ELISA for in-process samples from recombinant
protein production in CHO K1 cell lysate. The assay uses fluorescent-based
differential in blot electrophoresis (DIBE) technology that increases the accuracy of HCP detection by generating coverage data with a single gel.
These kits complement 2D DIBE technology, Amersham Typhoon™ scanner, and Melanie™ Coverage software to provide an efficient end-to-end
solution for accurately monitoring HCPs in drug samples. GE provides a
full line of products and technical support to help biopharma labs with
their HCP workflows.
For more information, visit: cytiva.com/HCP-analysis
Amersham, DIBE, and Typhoon are trademarks of Cytiva.
Melanie is a trademark of SIB Swiss Institute of Bioinformatics.



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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
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Cytiva eBook - 18
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