KRIBIOLISA™ Pichia Pastoris HCP ELISA

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.