Monoclonal antibody composition purification method

• Main Authors: SHEN WENTING, ZHENG SHUJIAN
• Format: Patent
• Language: Chinese; English
• Published: 18.03.2022
• Subjects: CHEMISTRY; METALLURGY; ORGANIC CHEMISTRY; PEPTIDES

The invention relates to the field of biological pharmacy, in particular to a monoclonal antibody composition purification method which comprises the following steps: S1, treating a monoclonal antibody composition through mesoporous silica microspheres, and removing lipid substances in the composition to obtain an intermediate; s2, further separating the intermediate through any one of an ammonium sulfate two-step method and an octanoic acid-ammonium sulfate two-step method to obtain a monoclonal antibody; wherein the monoclonal antibody composition comprises water, fat, impurity protein and a monoclonal antibody. According to the technical scheme, fat impurities in the monoclonal antibody composition can be effectively removed through the mesoporous silica microspheres, and the obtained final monoclonal antibody has relatively high purity and relatively small loss. 本申请涉及生物制药领域，具体涉及一种单克隆抗体组合物提纯方法，包括如下步骤：S1、通过介孔二氧化硅微球对单克隆抗体组合物进行处理，除去组合物中的脂类物质，得到中间物；S2、通过硫酸铵两步法或辛酸-硫酸铵两步法中的任意一种对中间物进行进一步分离，得到单克隆抗体；其中，单克隆抗体组合物中包括水