83-2272-11　［受注停止］KRIBIOLISA E.coli HCP ELISA 1 x 96 wells　KBBP01

特徴

• Description：Immunoassay for the measurement of E.coli Host Cell Proteins
• A variety of proteins and pDNA which are used as therapeutic agents in humans and animals are produced
• through recombinant expression in E.coli.
• The manufacturing and purification process of these products tends to
• leave the potential for contamination by Host Cell Proteins （HCPs） from E.coli 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 E-coli HCPs are reacted with anti-
• E.coli：HRP antibody simultaneously in the microtiter wells already coated with affinity purified capture anti-E.coli
• antibody.
• This immunological reaction results in formation of a sandwich complex of solid phase antibody-HCP-
• enzyme labeled antibody.
• The wells are washed to remove any unbound reactants as per the wash procedure
• （see Assay procedure section mentioned below）.
• The substrate 3,3',5,5' Tetramethyl Benzidine is then reacted.
• The amount of hydrolyzed substrate is read on a microtiter plate reader and it is directly proportional to the
• concentration of E.coli HCPs present.