Development and Validation of the ELISA Method for Anti-trastuzumab Antibodies Determination in Human Serum

Introduction. One of the widely used specific anti-HER 2 (human epidermal growth factor receptor 2) MAb drugs is trastuzumab. Trastuzumab highly effective for malignant HER hyperexpression reduction, which results in oncogenicity decrease. As any other biotherapeutics trastuzumab can cause immunological adverse reactions, e.g. immunogenicity or anti-drug antibodies (ADAs) production. Aim. The aim this study was to develop and validate analytical method anti-trastuzumab determination human blood serum. Materials methods. semi-quantitative antibody carried out by ELISA combined with ACE technique, using spectrophotometric detection visible range spectrum. Results discussion. developed validated cut point, selectivity, sensitivity, "hook" effect, drug tolerance, precision stability (short-term long-term). To decrease background noise from non-specific binding sera components, minimum required dilution value determined at 10 % calculated values screening point (normalization factor) confirmatory were 0.004 34.59 %, respectively. sensitivity estimated 99.5 ng/mL antibodies. Conclusion. obtained allow us use serum during safety clinical trials.