实验室水平单克隆抗体制备方法及相应纯化策略的研究进展

Progress in research on methods for preparation of monoclonal antibody at laboratory level and relevant purification strategy

单克隆抗体(monoclonal antibody,mAb)是由单一B细胞产生的高度均一、仅针对某一特定抗原表位的抗体。mAb已广泛应用于酶联免疫吸附试验、放射免疫分析、免疫组化和流式细胞术等医学诊断技术;并可作为亲和层析中重要的配体用于蛋白质的提纯;也可与化疗药物或放疗物质连接,利用mAb的导向作用,直接杀伤靶细胞,用于肿瘤导向治疗。mAb的纯度是其产品重要的质量指标之一,不同方法制备的mAb需根据其物理化学属性(等电点、分子量、疏水性等)来选择不同的纯化步骤,去除不同的杂质,以满足实验需求。本文就实验室水平的mAb制备方法及去除制备过程中产生污染物相应纯化策略的研究进展作一综述。

Monoclonal antibody(mAb)is a highly homogeneous antibody against a specified antigenic epitope,which is produced by a single B cell and has been widely used for medical diagnostic techniques such as enzyme linked immunosorbent assay(ELISA),radioimmunoassay(RIA),immunohistochemical assay and flow cytometry.The mAb may be used as a key ligand in affinity chromatography for protein purification,and for guided therapy of tumors by directly killing target cells through its guiding effect in combination with chemotherapeutic drugs or radiotherapy.Purity is a key quality index of mAb.Purification process should be selected according to the physical and chemical properties(such as isoelectric point,relative molecular mass and hydrophobicity)of mAbs prepared by various methods to remove different foreign matters and meet the experimental requirements.This article reviews the progress in research on methods for preparation of monoclonal antibody at laboratory level and the relevant purification strategy to remove the contaminants produced during preparation.