抗Her-2单克隆抗体A及上市原研药生物学活性研究及评价  

Research and evaluation on biological activities of anti-Her2 antibody A and innovative drug

作　　者：丁丁 梁锦锋 缪仕伟 王艳 王海彬 

机构地区：[1]海正药业(杭州)有限公司,杭州311404 [2]浙江省药品化妆品审评中心,杭州310012 [3]浙江海正药业股份有限公司,台州318000

出　　处：《中国新药杂志》2015年第20期2388-2394,共7页Chinese Journal of New Drugs

摘　　要：目的:评价抗Her-2单克隆抗体A的生物学活性并与上市原研药进行比较。方法:利用表面等离子共振技术比较抗Her-2单克隆抗体A及上市原研药的抗原-抗体结合活性;利用BT-474细胞模型测定抗Her-2单克隆抗体A对肿瘤细胞的生长抑制活性并与上市原研药进行比较;以SK-BR-3细胞作为靶细胞,NK92MI-CD16a作为效应细胞,检测抗Her-2单克隆抗体A的抗体依赖的细胞介导的细胞杀伤作用(antibody-dependent cell-mediated cytotoxicity,ADCC),并与上市原研药进行比较。结果:抗Her-2单克隆抗体A抗原抗体结合活性、对BT-474细胞的生长抑制活性以及ADCC活性批间一致,并与上市原研药高度相似。结论:抗Her-2单克隆抗体A的抗原抗体生物学活性批间一致,并与上市原研药具有高度的相似性和可比性。Objective： To assess biological activities of anti-Her2 antibody A and to compare these with those of innovative drug. Methods： The antigen-antibody binding affinities of anti-Her2 antibody A and innovative drug were compared using surface plasmon resonance technology. The inhibition effects of anti-Her2 antibody A and innovative drug on tumor cell growth were determined and compared using a BT-474 cell model. The antibody-dependent cell-mediated cytotoxicity（ ADCC） of anti-Her2 antibody A and innovative drug were evaluated using SKBR-3 cells as target cells and NK92MI-CD16 a cells as effector cells. Results： All the antigen-antibody binding affinities,the inhibition activities on BT-474 cell growth and ADCC of anti-Her2 antibody A were highly consistent and highly comparable with those of innovative drug. Conclusion： The biological activities of anti-Her2 antibody A are consistent from batch to batch,and have high similarity and comparability with those of innovative drug.

关 键 词：单克隆抗体 抗原抗体结合活性 表面等离子共振 增殖抑制 抗体依赖的细胞介导的细胞杀伤作用 

分 类 号：R917[医药卫生—药物分析学]