Author(s): ZHANG Feng, XU Gang-ling, YU Chuan-fei, WANG Wen-bo, CHEN Wei, LIU Chun-yu, WANG Lan, GAO Kai, Division of Monoclonal antibody Products, National Institutes for Food and Drug Control
Pages: 2317-2323
Year: 2015 Issue:  20
Journal: Chinese Journal of New Drugs
Keyword:  vascular endothelial growth factor(VEGF); monoclonal antibody; biological potency; quality control;
Abstract: Objective: To optimize human umbilical vein endothelial cell( HUVEC) proliferation inhibitory assay,and compare the biological potency of 6 bevacizumab similar bio-therapeutic products( SBPs) with bevacizumab. Methods: Cell inoculum density,VEGF165 concentration and sample concentration were optimized to improve repeatability and accuracy of the method. Using optimized method,relative potencies of 6 bevacizumab SBPs were determined and compared with original drug. Results: After optimization,the signal / noise ratio was 1. 5 ~1. 8,and variation < 20% within plates. The optimized assay had a good repeatability and accuracy within the potency range of 70% ~ 130%. Using the optimized assay,the relative potency of product control was 102. 00%.Relative potencies of 6 bevacizumab SBPs were determined as 95. 12%,88. 81%,96. 96%,103. 00%,105. 70%and 102. 40%. Conclusion: By optimization,the precision and accuracy of HUVEC proliferation inhibition assay are significantly elevated,which meets the requirements of potency comparison studies on bevacizumab and its SBPs.