鼠源性单克隆抗体F(ab′)2片段制备工艺
JOURNAL OF THE FORTH MILITARY MEDICAL UNIVERSITY(2000)
Abstract
目的制备符合临床应用质量标准的鼠源性mAb F(ab′)2片段.方法采用胃蛋白酶消化小鼠腹水抗体,疏水作用色谱法纯化F(ab′)2片段的新工艺,替代原有的木瓜蛋白酶消化IgG,阴离子交换色谱法纯化的旧工艺.结果新工艺所制备的F(ab′)2 片段经SDS-PAGE检测纯度达98%以上,ABC免疫组化法测定免疫活性为1∶8000,回收率大于 50%,核酸含量及热原均合格,整个工艺流程可在48 h内完成.结论新工艺制备人用鼠源性mAb F(ab′)2片段更简便高效、安全实用,能够适应中试放大及大规模生产的要求.
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