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Host Cell Proteins - HCP (E.coli) ELISA kit

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    Host Cell Proteins - HCP (E.coli) ELISA kit
  • Host Cell Proteins - HCP (E.coli) ELISA kit
Cat No: A05034
Assays - Hrp Kits
Price is excluding VAT and does not include packaging neither shipping

Enzyme ImmunoAssay (EIA) is a technique to detect and quantify antigens (proteins, hormones…) or antibodies in samples. It relies on the ability of an antibody to bind a specific antigen. Either the antibody or the antigen is labelled with an enzyme wh...

: 96 wells
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Territorial Availability: Available worldwide directly through Bertin Technologies or your local distributor
Technical Warning: Check the Additional Items Required section of this kit booklet to verify if UltraPure Water (Milli-Q or equivalent) is needed for this assay
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Product Overview:
Enzyme ImmunoAssay (EIA) is a technique to detect and quantify antigens (proteins, hormones…) or antibodies in samples. It relies on the ability of an antibody to bind a specific antigen. Either the antibody or the antigen is labelled with an enzyme whose substrate is a chromogen or a fluorogen converted in a measurable product (color or fluorescence).
Enzyme-linked Immunosorbent Assay (ELISA) is a type of EIA using a solid phase (ex: microtiter plate) coated with an antigen immobilizing the molecule to detect. Over the time, scientists have extended the term ELISA to EIAs using an antibody coating the solid phase. That explains why our EIA kits using coated antibodies are also called ELISA kits.
Impurity assessment is a key step during the drug development production of recombinant proteins, including therapeutic proteins. Specific impurities coming from the cells mediating the protein expression, known as Host Cell Proteins (HCP) are generated and need to be removed. This kit is intended for use in assessing relative quantities of E. coli HCP in manufactured or research bioproducts.
Polyclonal antibodies used in this kit have been generated against several strains of E.coli and specifically selected for their recognition of a large spectrum of E. coli proteins. Thus, this kit can be considered as generic and allows a relative-quantitative determination of E. coli HCP in many types of samples, such as samples issued from the purification process (HCP clearance), process control, quality control, or product release.
Using this kit, HCP concentration is measured in ng/ml (HCP equivalent is extrapolated from a standard curve). Conventionally, the HCP content in a product will finally be expressed in ng/mg, where ng represents HCP mass and mg represents the product mass. Note that, contrary to the concentration measurement of the product, the HCP signal is only reflective of antibody binding and does not strictly reflect the mass of HCP.
This kit has been successfully validated for recovery and precision using reconstituted HCP samples and tested against different final products. Given the diversity of final products, all potential matrix effects cannot be known and it is recommended that you test the suitability of the kit for use with your own HCP samples in your laboratory.
This kit should be used as one part of your complete HCP analysis.
Size: 96 wells
Shipping: wet ice
Stability: Store at +4degrees; shelf life 6 months maximum after production
Sample volume: 100 µL
Tracer: HRP
Detection Limit: 2,0 ng/mL
Standard Curve Range: 4,1 - 3000 ng/mL
Custom Code: 3822000000
UNSPSC code: 41116104


US Pharmacopeial Convention. Residual Host Cell Protein Measurement in Biopharmaceuticals. HCP IMMUNOASSAY METHOD VALIDATION/4.3 Sample Linearity/Table 4 - Second Supplement to USP38-NF33 p. 7647 1st April 2016

Tscheliessnig AL. et al. Host cell protein analysis in therapeutic protein bioprocessing methods and applications. Biotechnol J. 2013, 8(6):655-70

Wang X et al. Host cell proteins in biologics development: Identification, quantitation and risk assessment. Biotechnol Bioeng. 2009, 103(3):446-58


Valentin MA, Ma S, Zhao A, Legay F, Avrameas A. Validation of immunoassay for protein biomarkers: Bioanalytical study plan implementation to support pre-clinical and clinical studies. J Pharm Biomed Anal. (2011) 55(5): 869-877

European Medicines Agency. Guideline on bioanalytical method validation, 21 July 2011

SPI-Bio is a brand name of Bertin Bioreagent.
Bertin Bioreagent includes over 100 employees, chemists, biochemists, immunoanalysts, pharmacists and technicians.
Always at the forefront of innovation and after launching on the market products incorporating in their time innovative technologies (Acetylcholinesterase tracer for EIA), this brand offers a wide and unique range of assays for biomarker Immunoassays (SPI-Bio TM) thanks to a solid knowledge acquired during the last 25 years in developping over 100 biomarkers assays.

To better serve you, we aim to design our products and reagents to address your needs on the expected performance in terms of a possible range of use, but also on operational conditions of use & regulations.
Thanks to our production processes and quality controls, we provide you with products with compliance to specifications.
Our technical support & science teams are available to help you assess their relevance depending on your needs, to specify the conditions of application and their fields of use. Finally, our researchers are ready to provide you with the necessary support by going, if needed, in your laboratories to validate your operating conditions and to solve possible problems.

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