特徴

• Description：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.￥