Principle of the Assay: CHO HCP ELISA kit applies the quantitative sandwich enzyme immunoassay technique. The microtiter plate has been pre-coated with a polyclonal antibody specific for CHO HCP. Standards or samples are then added to the microtiter plate wells and CHO HCP if present, will bind to the antibody pre-coated wells. In order to quantitatively determine the amount of CHO HCP present in the sample, a standardized preparation of horseradish peroxidase (HRP)-conjugated polyclonal antibody, specific for CHO HCP are added to each well to "sandwich" the CHO HCP immobilized on the plate. The microtiter plate undergoes incubation, and then the wells are thoroughly washed to remove all unbound components. Next, substrate solutions are added to each well. The enzyme (HRP) and substrate are allowed to react over a short incubation period. Only those wells that contain CHO HCP and enzyme-conjugated antibody will exhibit a change in color. The enzyme-substrate reaction is terminated by addition of a sulphuric acid solution and the color change is measured spectrophotometrically at a wavelength of 450 nm. A standard curve is plotted relating the intensity of the color (O.D.) to the concentration of standards. The CHO HCP concentration in each sample is interpolated from this standard curve.
Background/Introduction: CHO cell line is widely used in the expression of therapeutic protein, which is a cost effective method for production of commercial quantities of a drug substance. One of the goal in designing a downstream process for biopharmaceutical products is to remove any possible contaminants, including host cell proteins. HCPs can still be present at significant concentrations following several purification steps and can even be co-purified and concentrated with the drug substance itself. HCP in the products will result in adverse toxic or immunological reactions which compromise product safety and quality. This it is desirable to reduce the host cell protein contamination to the lowest level. Therefore, during the development of a downstream process, suitable assays must be available to determine the amount of HCP present. This highly sensitive ELISA kit has been successfully validated for a range of drug substances. It can be used for the quantification of CHO HCP proteins in routine bioprocess operations, from the very crude harvest material to the final product.
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Product Notes
The CHO Host Cell Proteins (Catalog #AAA3809911) is an ELISA Kit and is intended for research purposes only. The product is available for immediate purchase. It is sometimes possible for the material contained within the vial of "CHO Host Cell Proteins, ELISA Kit" to become dispersed throughout the inside of the vial, particularly around the seal of said vial, during shipment and storage. We always suggest centrifuging these vials to consolidate all of the liquid away from the lid and to the bottom of the vial prior to opening. Please be advised that certain products may require dry ice for shipping and that, if this is the case, an additional dry ice fee may also be required.Precautions
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