单克隆抗体F(ab’)_2片段的制备与质量控制

本文在F(ab’) 2 片段抗体的制备工艺上 ,采用HPLC疏水色谱法 ,用高性能的疏水色谱柱 ,经 2次纯化后的F(ab’) 2 纯度可大于 98% ,回收率大于 5 0 % ,整个过程控制无菌无热原 ,纯化后产品经检定完全符合有关人用鼠源性单抗质量控制标准 ,适宜做大规模生产。

Preparation and Quality Control of F(ab')_2 Fragments of Murine Monoclonal Antibodies

The F(ab') 2 fragments of murine monoclonal antibodies were prepared according to the clinincal quality standard. The fragments were purified from the McAb IgG 1 digested with pepsin by hydrophobic integration HPLC using phenyl separose high performance column. The purity and recovery rate of the fragments were above 98% and more than 50% respectively. The whole technological process was under the condition of sterility and free pyrogen. The product of F(ab') 2 fragment was stable at 4℃ for one year. The product reached the clinical quality standard published by National Institute for the Control of Pharmaceutical and Biological Products and was suitable for large scale production.