KRIBIOLISA™ Anti-Atezolizumab (TECENTRIQ) ELISA

250 ng/ml - 2500 ng/ml

Colorimetric, 450nm

Enzyme Immunoassay for the Quantitative Determination of AntiAtezolizumab in human serum and plasma. Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). In 2015, it was in clinical trials as an immunotherapy for several types of solid tumors. It was under investigation by Genentech/Roche. In April 2016, Roche announced that atezolizumab had been granted fast track status for lung cancer by the FDA.In May 2018, Tecentriq was in combination with Avastin and standard chemotherapy for some patients with lung cancer was granted priority review. 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 Atezolizumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects antibodies for Anti-Atezolizumab 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 competitive enzyme immunoassay technique. Atezolizumab is pre-coated onto microwells. Samples or standards along with the tracer are pipetted into microwells and antibodies to Atezolizumab present in the standards or sample will compete with tracer and bound by the capture antibody. After washing microwells, HRP conjugate is pipetted and incubated. Free HRP conjugate will be removed by washing cycle. The ready to use substrate solution (TMB) is added to microwells and color develops inversely proportionally to the amount of Anti-Atezolizumab present in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Serum and Plasma

62.5 ng/ml