GenScript Trastuzumab Immunogenicity Kit (Bridging ELISA)

GenScript Trastuzumab, also known as Herceptin, is a human epidermal growth factor receptor 2 (HER2) inhibitor for the treatment of breast cancer. Trastuzumab is a recombinant humanized IgG1 kappa monoclonal antibody. It binds to the extracellular domain of the HER2 protein on the on the surface of HER2-positive tumor cells with high affinity. Trastuzumab can suppress the cells growth and proliferation by blocking the ability of the cancer cells to receive chemical signals.
Antibody drugs have the possibility to generate anti-drug antibodies (ADAs), which may alter drug clearance and neutralize target binding, causing reduction of drug efficacy. The immunogenicity of antibody drugs may cause anaphylaxis, infusion reactions, and immune complex disorders. Therefore, it is important to assess the presence and impact of Trastuzumab ADAs on exposure, safety, and efficacy.
GenScript Trastuzumab Immunogenicity Kit (Bridging ELISA) is designed for detection of anti-Trastuzumab antibody in serum and plasma samples. This kit utilizes a validated bridging immunoassay method based on the FDA, EMA and NMPA Immunogenicity Guidelines. Through rigorous validation studies, the kit has been demonstrated high sensitivity, specificity, and is free from matrix effects. It is an ideal tool for the analysis of ADA against Trastuzumab. - GSCRPT (Additional S&H or Hazmat Fees May Apply)