83-2272-12　［受注停止］KRIBIOLISA Pichia Pastoris HCP ELISA 1 x 96 wells　KBBP02

特徴

• Description：Immunoassay for quantitative determination of P.
• pastoris 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 P.pastoris.
• The manufacturing and purification process of these products
• tends to leave the potential for contamination by Host Cell Proteins （HCPs） from P.pastoris 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 P.pastoris HCPs are reacted with
• already coated affinity purified capture anti-P.pastoris antibody and bind to them.
• Plates are washed with wash
• buffer to remove unbound reactants.
• Anti P.pastoris-HRP conjugate is added which results in the 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.
• The substrate 3, 3',5, 5' Tetra Methyl 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 P.
• pastoris HCPs present.