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Host cell proteins (HCP) are one of the impurity contaminants in the production process of biologics, and even trace amounts can seriously affect the final quality and safety of biologics. At Creative Biogene, we recognize the importance of monitoring and eliminating any residual HCP during the production of biologics. Our team of scientists has successfully developed a range of advanced detection technologies. These cutting-edge methods ensure reliable detection and accurate quantification of HCP to ensure the quality and safety of biologics.
Host Cell Protein (HCP) is a multi-protein complex derived from the host cells from which the cell line was produced, with the potential risk of causing allergic and hypersensitivity reactions in humans. In addition, HCP can directly alter the quality of the product itself, leading to potential hazards, including affecting the stability and biological activity of monoclonal antibodies, degrading lipid stabilizers (polysorbates) in drug formulations leading to shorter drug shelf life, causing allergies, cytotoxicity, or signaling, etc., with negative biological effects on patients. Therefore, precise assay techniques are needed to analyze the level of potential HCPs and remove these impurities during biologics development to ensure drug purity, manufacturing process consistency, and patient safety.
Creative Biogene offers a range of advanced HCP assays and technologies. Our experienced experts can provide customized assays based on HCP type, content and process. Whether monitoring HCP in APIs, process intermediates or products, we can provide accurate and reliable results to ensure product safety and quality.
| Methods | Description | Advantages |
|---|---|---|
| ELISA | ELISA is a widely used method for HCP testing. It involves the use of specific antibodies that can selectively bind to HCPs and create a measurable signal. |
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| Mass spectrometry (MS) | Mass spectrometry, which involves ionizing proteins and analyzing their mass-to-charge ratios, can be used to accurately identify and quantify HCP. |
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| Western blotting | Accurately detect and characterize HCP with our efficient Western blotting kits and equipment. |
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| 2D electrophoresis | Proteins are separated by isoelectric point (pI) in the first dimension and then by molecular mass in the second dimension. The separated proteins are then visualized using staining techniques. |
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Creative Biogene specializes in Residual Host Cell Protein Testing services for a diverse array of host cells, including but not limited to human cells, HEK293, CHO, Vero, NS0, MDCK, E. coli, and Pichia pastoris. Additionally, we offer custom assay development services for unique or specialized host cells. Our expertise ensures precise, reliable results tailored to meet the specific requirements of your unique cell line, enabling advanced research and development in biotechnology and pharmaceutical applications. Partner with Creative Biogene for customized solutions that cater to the nuanced demands of your special host cells.
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