KRIBIOLISA™ Daratumumab (DARZALEX) ELISA

Enzyme Immunoassay for the quantitative determination of Daratumumab in serum, plasma and cell culture supernatant. Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells overexpress. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.Daratumumab was given breakthrough therapy drug status in 2013 for multiple myeloma. It was awarded orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma. Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well. 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 The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Daratumumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Daratumumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Daratumumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Daratumumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.