Establishment of analytical method for biological activity of IL-17A monoclonal antibody

OBJECTIVE To establish two analytical method to determine the biological activity of IL-17A monoclonal antibody. METHODS ①The biological activity of IL-17A was detected by BIAcore T200 analysis method based on surface plasma resonance(SPR). ②Determine the biological activity of il-17a monoclonal antibody by IL-6 release inhibition method. RESULTS The optimum pH value of coupling obtained by SPR method was 5.0, the kinetic constant was 0.100 86 nmol·L^-1, and the sample concentration was 2.062 5-33 nmol·L^-1. The curve fitting constants R²detected by IL-6 release inhibition method met the requirements of >0.95, the relative activity was 80%-125%, and the RSD of multiple tests was ≤ 20%, which met the repeatability verification standard and met the requirements. CONCLUSION The results of the two detection methods are good, which can effectively reflect the biological activity of IL-17A, and can be used to detect the biological activity of IL-17A monoclonal antibody simply and quickly.