论文部分内容阅读
生产静脉注射免疫球蛋白(IVIG)制品面临着既要清除具有抗补体作用的IgG聚合物、又不至于影响制剂中抗体活性的问题。用胃蛋白酶或纤维蛋白溶酶(以下简称纤溶酶)裂解及化学修饰方法(包括β-丙内酯、磺化、或还原/烷基化等)可达到这个目的。以往,IgG分子的抗体滴度是衡量制品有效性的唯一基础。但是现在知道IgG分子Fc段的效应功能,诸如调理吞噬作用、补体致溶细胞作用以及抗体依赖性细胞毒性(ADCC)
The production of intravenous immunoglobulin (IVIG) preparations is confronted with the problem of removing both IgG polymers with anti-complement effects without affecting the antibody activity in the formulation. Pepsin or plasmin (hereinafter referred to as plasmin) lysis and chemical modification methods (including β-propiolactone, sulfonation, or reduction / alkylation, etc.) can achieve this goal. In the past, antibody titers of IgG molecules were the only basis for measuring the effectiveness of an article. However, it is now known that the effector functions of the Fc fragment of IgG molecules, such as opsonophagocytosis, complement-causing cell function and antibody-dependent cellular cytotoxicity (ADCC)