KRIBIOLISA™ Anti-Ustekinumab (STELARA) ELISA

0 ng/ml - 320 ng/ml

Colorimetric, 450nm

Enzyme Immunoassay for the quantitative determination of AntiUstekinumab in serum, plasma and cell culture supernatant. Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12and interleukin 23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. In two Phase III trials for moderate to severe psoriasis, the longest >76 weeks, ustekinumab was safe and effective. A third Phase III trial, ACCEPT, compared the efficacy and safety of ustekinumab with etanercept in the treatment of moderate to severe plaque psoriasis. This trial found a significantly higher clinical response with ustekinumab over the 12-week study period compared to high-dose etanercept. It also demonstrated the clinical benefit of ustekinumab among patients who failed to respond to etanercept. Ustekinumab is approved in Canada, Europe and the United States to treat moderate to severe plaque psoriasis. 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 Etanercept and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Etanercept 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. Ustekinumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Ustekinumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Ustekinumab 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-Ustekinumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Serum and Plasma

5ng/ml