新型混合模式层析技术在单克隆抗体精细纯化中的应用

Application of Mixed Mode Chromatography to Polishing Purification of Monoclonal Antibody

单克隆抗体(简称单抗)产品纯化工艺中需引入高效的精细纯化步骤,并对每步工艺去除各种杂质的能力进行深入研究。精细纯化可去除特定杂质,对产品的最终质量至关重要。工业上主要采用离子交换、疏水层析等技术,而新型的混合模式层析技术在单抗的精细纯化中正得到越来越广泛的应用。本文对适合工业化生产的疏水性电荷诱导层析、多模式阴离子交换层析、羟基磷灰石层析等几种新型混合模式层析技术的作用机制、层析条件中的关键影响因素及其去除杂质的能力作一综述。

Highly effective polishing purification shall be introduced to purification procedure of monoclonal antibody（McAb）,and each step of the procedure shall be verified for the ability of removing foreign matters.Polishing purification techniques,such as ion exchange chromatography and hydrophobic chromatography,may be used for removing special matters,which are of important significance in the qualities of final products.However,a novel mixed mode chromatography is increasingly used for the polishing purification of McAb.The principles,key influencing factors and the abilities in removing foreign matters of various polishing purification methods suitable for industrial production,including hydrophobic charge induction chromatography,multi-modal anion exchange and hydroxyapatite chromatography,are reviewed in this paper.