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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
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
丁 丁1,梁锦锋2,缪仕伟1,王 艳1,王海彬3

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
Research and evaluation on biological activities of anti-Her2 antibody A and innovative drug
(1 HisunPharma (Hangzhou) Co., Ltd., Hangzhou 311404, China; 2 Zhejiang Center for Drug and Cosmetic Evaluation, Hangzhou 310012,China;3 Zhejiang Hisun Pharmaceutical Co., Ltd., Taizhou 318000, China)

摘要参考文献相关文章

起始页:2388

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。

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

通讯作者:王海彬,女,博士,浙江海正药业股份有限公司高级副总裁。

基金项目:

作者简介:丁丁,男,博士,主要从事蛋白质药物质量表征研究。

Abstract: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 SK-BR-3 cells as target cells and NK92MI-CD16a 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.

Key words:monoclonal antibody; antigen-antibody-binding affinity; surface plasmon resonance; growth inhibition; antibody-dependent cell-mediated cytotoxicity



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