单克隆抗体纯化中的柱层析与膜层析效果比较  

Comparison of the Effects of Column Chromatography and Membrane Chromatography in the Purification of Monoclonal Antibodies

作　　者：李谦 赵鸿阳 梁晓莹 王子臣 樊梦妮 孔霄玥 吴涛 何清泉 李国柱 秦国宏 LI Qian;ZHAO Hongyang;LIANG Xiaoying;WANG Zichen;FAN Mengni;KONG Xiaoyue;WU Tao;HE Qingquan;LI Guozhu;QIN Guohong(Fanghua Pharmaceutical Research Institute,Department of Biology,Nanjing China Tai Tianqing Pharmaceutical Co.,Ltd.,Nanjing 210046,China)

机构地区：[1]南京正大天晴制药有限公司芳华药物研究院生物所,江苏南京210046

出　　处：《山东化工》2025年第4期166-171,共6页Shandong Chemical Industry

摘　　要：单克隆抗体近年来逐渐占据治疗性药物的半壁江山,成为众多研发机构研发的焦点。近年来随着上游细胞培养工艺技术的发展,抗体的表达水平越来越高。这就给下游抗体纯化工艺带来一定挑战。传统的纯化工艺通过不同类型的层析柱来对单克隆抗体进行纯化。但是,柱层析具有工艺时间长,工艺成本高的缺点。近年来,膜材料的发展,膜层析逐渐应用于下游纯化中。本研究比较了膜层析与柱层析的差异,结果表明,经过膜层析与柱层析纯化后的单克隆抗体具有相似的质量属性,表明膜层析具有一定的可替代性。并且膜层析相比于柱层析能显著提高工艺流速,其中亲和膜层析的工艺流速比柱层析快200倍,阴离子膜层析比柱层析工艺流速快50倍。因此采用膜层析进行单克隆抗体纯化工艺开发可以极大程度上节约时间成本。本研究以期为单克隆抗体快速纯化工艺开发提供参考。Monoclonal antibodies have increasingly dominated the therapeutic drug market in recent years,becoming a focus for many research and development institutions.With advancements in upstream cell culture technologies,antibody expression levels have been rising,posing challenges to downstream purification processes.Traditional purification processes use various types of chromatography columns to purify monoclonal antibodies.However,column chromatography has disadvantages such as long processing times and high costs.In recent years,the development of membrane materials has led to the application of membrane chromatography in downstream purification processes.This study compares the differences between membrane chromatography and column chromatography.The results show that monoclonal antibodies purified by both methods exhibit similar quality attributes,indicating that membrane chromatography is a viable alternative.Moreover,membrane chromatography significantly increases process flow rates compared to column chromatography,with affinity membrane chromatography being 200 times faster and anion exchange membrane chromatography being 50 times faster than their respective column chromatography counterparts.Therefore,using membrane chromatography for the development of monoclonal antibody purification processes can greatly reduce time and cost.This study aims to provide reference for rapid purification process development of monoclonal antibodies.

关 键 词：单克隆抗体 膜层析 柱层析 工艺开发 

分 类 号：TQ460[化学工程—制药化工]