KRIBIOLISA™ Vedolizumab (ENTYVIO) ELISA

Enzyme Immunoassay for the quantitative determination of Vedolizumab (ENTYVIO) in serum, plasma and cell culture supernatant. Vedolizumab is a recombinant humanized IgG1 monoclonal antibody directed against the human lymphocyte α4β7 integrin, a key mediator of gastrointestinal inflammation. It is used in the treatment of moderate to severe active ulcerative colitis and Crohn's disease for patients who have had an inadequate response with, lost response to, or were intolerant to inhibitors of tumor necrosis factor-alpha (TNF-alpha) or other conventional therapies. By blocking its primary target, α4β7 integrin, vedolizumab reduces inflammation in the gut. 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 Vedolizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Vedolizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Vedolizumab 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 Vedolizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.