Introduction
Host cell proteins (HCPs) are low-level, process-related protein impurities in drug products derived from host
organisms during biotherapeutic manufacturing. During the expression of recombinant protein drugs, the host cell
system can express many endogenous proteins. Purification of drugs from these HCP contaminants can be challenging,
leaving low levels of contaminants after purification, and host cell proteins (HCPs) accompanying recombinant
biotherapeutics can significantly affect drug efficacy and cause immunogenicity. According to guidance for
regulatory agencies (ICH Q6B), the detection and quantification of residual HCPs as potential process-related
impurities is critical for biopharmaceutical companies.
ELISA technology that relies on antibody recognition can perform qualitative and quantitative analysis of HCP
proteins, which is currently the most widely used technology. However, the premise of accurate qualitative and
quantitative analysis of HCP proteins using ELISA technology is the standard products and corresponding antibodies
of these HCP proteins. There are more than thousands of HCP proteins. Due to the lack of standard products and
corresponding antibodies, it is impossible to effectively apply ELISA technology for qualitative and quantitative
analysis of all proteins. In order to make up for the shortcomings of ELISA technology, Creative
Proteomics provides qualitative and quantitative analysis of HCP proteins based on LC-MS technology,
our experts will deploy the best methods to test your biopharmaceuticals at the drug discovery stage.
Fig.
1. Detection and quantitation of host cell proteins in monoclonal antibody drug products using LC-MS/MS. (Strasser
L, et al., 2021)
Our Services
Host cell protein (HCP) impurities are critical quality attributes that have the potential to negatively impact the
quality and safety of biopharmaceutical products. Since HCPs are often present in low levels, developing highly
sensitive analytical methods to identify and quantify them is critical for process optimization and improvements to
reduce their content in final drug products are critical. Thanks to best-in-class mass spectrometry experience,
Creative Proteomics has developed an advanced host cell protein profiling platform.
For regulatory filings, LC-MS has been an orthogonal method that supports and complements Ligand Binding Assays
(LBAs) such as ELISA. Therefore, Creative Proteomics provides innovative and powerful LC-MS
expertise and software tools for characterizing and quantifying host cell protein impurities. With our solutions, we
support your bioprocessing, improve your downstream processes and enhance your regulatory information.
At Creative Proteomics, our highly qualified scientists first extract host cell whole protein,
trypsinize and enrich, and then perform shotgun proteomics analysis to identify HCPs in antibody drug substances.
We Can Provide but Not Limited to:
- Whole protein extraction of host cell.
- Qualitative identification of host cell proteins.
- Quantitative analysis of host cell proteins.
- Characterize HCP originated from multiple species.
- Comprehensive and accurate evaluation of residual HCP.
Advantages of Our LC-MS Based Host Residual Protein Analysis Service
- Compared with the traditional ELISA and 2D methods, the LC-MS method specifically confirm and quantify all HCPs,
and unbiasedly detect all impurity proteins.
- Wide dynamic range and high sensitivity: The detection dynamic range of mass spectrometry is 6 orders of
magnitude, which meets the detection of most HCP proteins.
- The protein does not need to be labeled, the total amount of sample required is small with low cost.
- Highly efficient analysis and short turnaround time: 5-7 days for comprehensive reports.
- Customized service: The optimization method will be customized according to your sample type and size.
Creative Proteomics is a reliable biopharmaceutical partner. Our professional team can provide
high-quality LC-MS based host residual protein analysis service for global customers. We will provide clear,
comprehensive written reports, recommendations and agreements, as well as customized services to help clients solve
analytical and technical problems. If you would like more information on a specific aspect of our services, please
do not hesitate to contact us, we will be happy to answer any questions.
References
- Strasser L, Oliviero G, Jakes C, et al. (2021) Detection and quantitation of host cell proteins in
monoclonal antibody drug products using automated sample preparation and data-independent acquisition
LC-MS/MS.J Pharm Anal. 11(6):726-731.
- Chen Y, Xu C F, Stanley B, et al. (2021) A Highly Sensitive LC-MS/MS Method for Targeted Quantitation
of Lipase Host Cell Proteins in Biotherapeutics.J Pharm Sci. 110(12):3811-3818.
