KRIBIOLISA™ Anti-Trastuzumab (HERCEPTIN) ELISA

Enzyme Immunoassay for the Quantitative Determination of AntiTrastuzumab in human serum and plasma. Trastuzumab is humanized monoclonal antibody which targets HER-2/neu receptor. Trastuzumab is approved for the use in treating Breast Cancer and is being tested for other cancers that over express HER-2/neu. AntiDrug 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 Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Trastuzumab 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. Trastuzumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Trastuzumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Trastuzumab 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-Trastuzumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.