KRIBIOLISA™ Anti-Ipilimumab (YERVOY) ELISA

0 ng/ml - 640 ng/ml

Colorimetric, 450nm

Enzyme Immunoassay for the quantitative determination of AntiIpilimumab in serum, plasma and cell culture supernatant. Ipilimumab (trade name Yervoy) is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, an inhibitory mechanism interrupts this destruction. Ipilimumab turns off this inhibitory mechanism and allows CTLs to function. Ipilimumab was approved by the U.S. FDA in 2011 for the treatment of melanoma, a type of skin cancer. It is undergoing clinical trials for the treatment of non-small cell lung carcinoma (NSCLC), small cell lung cancer (SCLC),bladder cancer and metastatic hormonerefractory prostate cancer.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 Ipilimumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Ipilimumab 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. Ipilimumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Ipilimumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Ipilimumab 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 theamount of Anti-Ipilimumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm

Serum and Plasma

36 ng/ml