KRIBIOLISA™ CHO HCP ELISA 

Immunoassay for the measurement of CHO Host Cell Proteins in biological preparations and cell culture supernatant A variety of proteins which are used as therapeutic agents in humans and animals are produced through recombinant expression in Chinese Hamster Ovary (CHO) cells. The manufacturing and purification process of these products tends to leave the potential for contamination by Host Cell Proteins (HCPs) from CHO cells, which may result in adverse toxic or immunological reactions that ultimately affect the efficacy of the therapeutic agent. The simple, objective and semi-quantitative ELISA is a highly sensitive method that aids in purification process development, process control, quality control and product release testing optimally. About the kit: - Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity. - Recovery rates are between 85 - 115% - Ready to use with a standard protocol with break-apart pre-coated wells - Validated as per US FDA guidelines for Bioassays - Optimized for matrix effects to ensure higher sensitivity. - Shelf life: 1 year This assay is based on the Sandwich ELISA procedure. Samples containing CHO HCPs are reacted with already coated affinity purified capture anti-CHO HCP antibody. Following an incubation period unbound components are removed by a washing step. Then the anti-CHO HCP: HRP is added. This immunological reaction results in formation of a sandwich complex of solid phase antibody-HCP-enzyme labeled antibody. The wells are again washed to remove any unbound reactants. The TMB substrate is then added to the well. The amount of hydrolyzed substrate is read on a microtiter plate reader and it is directly proportional to the concentration of CHO HCPs present.\