KRIBIOLISA™ Anti-Natalizumab (TYSABRI) ELISA

0 ng/ml - 640 ng/ml

Colorimetric, 450nm

Enzyme Immunoassay for the quantitative determination of AntiNatalizumab in serum, plasma and cell culture supernatant. Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule ?4-integrin. Natalizumab is used in the treatment of multiple sclerosis and Crohn's disease. It is co-marketed by Biogen and ?lan as Tysabri, and was previously named Antegren. Natalizumab is administered by intravenous infusion every 28 days. The drug is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood?brain barrier. Natalizumab has proven effective in treating the symptoms of both diseases, preventing relapse, vision loss, cognitive decline and significantly improving quality of life in people with multiple sclerosis, as well as increasing rates of remission and preventing relapse in Crohn's disease. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Natalizumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Natalizumab and may be used for monitoring immunogenicity. 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. Natalizumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Natalizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Natalizumab is pipetted and incubated. After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Anti-Natalizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Serum and Plasma

10 ng/ml