Immunogenic Host Cell Protein Analysis Service
Creative Biolabs provides clarity on your product's purity, a key element in a risk-based management strategy. We identify and quantify individual HCPs with unparalleled specificity, ensuring you can pinpoint and address the most critical, high-risk impurities that may affect product safety or stability. Our capabilities go beyond simple detection to provide actionable insights for process optimization, which can ultimately lead to a more robust, compliant, and commercially viable therapeutic.
Introduction What We Can Offer Workflow Why Creative Biolabs Customer Reviews FAQs Related Services Contact Us
Host Cell Protein
The primary problem with residual HCPs as exogenous proteins is that they trigger an immune response in patients when administered. Immune responses to exogenous proteins occur through a T cell-dependent pathway, where proteins are uptaken, digested, and presented by antigen-presenting cells, then recognized by T cells, followed by further activation and maturation by B cells expressing complementary antibodies. Although the scale of immunogenicity of CHO HCP is smaller than that of non-mammalian organisms such as E. coli or yeast, the sequence differences between CHO and human proteins are significant. In addition to direct immunogenicity, HCPs have the potential to induce and enhance anti-drug antibodies or induce immune responses to endogenous proteins.
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Fig.1 Overview of the HCP landscape in the context of biologics manufacture.1
What We Can Offer
Creative Biolabs offers, but is not limited to, the following HCP analysis methods.
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HCP analysis methods
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Description & Features
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ELISA
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Enzyme-linked immunosorbent assay (ELISA) is commonly used to measure total HCP concentration, the most commonly used of which is polyclonal antibodies produced by injecting HCPs from empty cell lines into animal models.
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1D/2D-PAGE
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1D polyacrylamide and 2D polyacrylamide gel electrophoresis (1D/2D-PAGE) have been widely used to study HCP kinetics at various stages of the biotherapeutic recombinant protein production workflow.
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LC-MS/MS
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2D-PAGE binds to LC-MS/MS, which can identify specific HCPs, and Western blotting can also be performed using anti-HCP antiserum or specific HCP antibodies.
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Protein Isoelectric Point
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The protein isoelectric point determination method is a commonly used analytical method to determine the isoelectric point of a protein. Commonly used methods for determining the isoelectric point of proteins include Isoelectric Focusing (IEF) and Isoelectric Point Electrophoresis (IEP).
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Others
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Novel detection techniques, such as proximity ligation assay (PLA) and biosensor technology, are also being used to detect HCPs.
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In addition to being used alone to detect HCP, the combination of these techniques can be more effective. If ELISA is combined with 2D-PAGE and western blotting is used, the coverage of antibodies in the ELISA can be verified, which can help improve the accuracy of the ELISA method. 2D-PAGE can also be combined with LC-MS/MS to identify specific HCP components and help identify high-risk factors.
HCP Analysis Service at Creative Biolabs
Highlights
Precision and Expertise
Creative Biolabs is a leader in biopharmaceutical analytics, offering the precision and expertise required to navigate the complexities of HCP analysis. We provide a truly risk-based management strategy by solving the most challenging problems in biologics development.
Beyond ELISA
While ELISA is an industry standard for total HCP burden, it is fundamentally limited in identifying and quantifying individual, highly immunogenic species that can pose risks to patients.
Multi-Platform Advantage
Our multi-platform approach provides the deep, granular data necessary for a truly risk-based management strategy. We combine multiple orthogonal technologies to deliver unparalleled insights and data quality.
Success and Reliability
Our published data and a track record of success stories demonstrate our commitment to solving the most challenging problems in biopharma. You can rely on our expertise to guide your project to completion.
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Customer Reviews
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Streamlined Process Development
The analysis from Creative Biolabs has greatly facilitated our process development. We used their service to compare the HCP profiles from two different purification protocols. The data clearly showed that one protocol was superior in clearing high-risk HCPs. - A***a L.
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Improved Product Stability
Using Creative Biolabs' immunogenic HCP analysis in our research has significantly improved our understanding of product stability. Their detailed LC-MS/MS data helped us pinpoint a specific protease from our host cell line, which we were then able to remove, preventing degradation of our therapeutic protein. We also found their reports very clear and actionable. - M***s R.
FAQs
Can you help us with a specific, custom HCP?
Absolutely. Our services are highly customizable. While our mass spectrometry approach can identify and quantify a broad range of HCPs, we can also design targeted studies to focus on specific, high-risk proteins that you are concerned about. Our team will work with you to tailor the analysis to your exact needs.
Why is a generic ELISA not sufficient for my project?
While generic ELISAs are great for routine total HCP measurement, they may not detect all proteins specific to your unique manufacturing process, especially low-abundance but highly immunogenic ones. Our multi-platform approach with mass spectrometry and other orthogonal methods provides a much deeper, more specific view of your HCP profile.
Related Services
T and B Cell-based ELISA Assay
We offer specialized assays to provide a deeper understanding of the cellular immune response to a therapeutic. These assays can identify T-cell epitopes and assess B-cell activation, providing crucial data for a complete immunogenicity risk assessment.
Learn More →
LC-MS/MS-based Quantitative Bioanalysis Service
Our state-of-the-art platforms are ideal for the precise quantification of a wide range of molecules, including small molecules, peptides, and oligonucleotides, providing critical data for PK/PD studies, metabolite identification, and biomarker discovery.
Learn More →
How to Contact Us
Based on years of continuous research in the fields of proteomics and genomics, Creative Biolabs has become more and more knowledgeable about HCP. Creative Biolabs offers customized HCP analysis services. In addition, we develop specific kit products for specific host cells and process nodes to ensure the quality and safety of your biologics. If you have a need for HCP analysis, please contact us now.
Reference
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Bracewell, Daniel G et al. "The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control." Biotechnology and bioengineering vol. 112,9 (2015): 1727-37. Distributed under an Open Access license CC BY 4.0, without modification. https://doi.org/10.1002/bit.25628
