Römer J, Späth P J, Skvaril F, Nydegger U E
Vox Sang. 1982 Feb;42(2):74-80. doi: 10.1159/000460851.
14 immunoglobulin preparations for intravenous use were tested to assess functions of their Fc portion. Inhibition of the hemolytic activity of complement, C1q binding and the interaction of IgG subclasses with Staphylococcus protein A were investigated. Complement studies were done on both the ready-for-infusion and the heat-aggregated preparations. Three groups of products could be distinguished: (1) Enzymatically and chemically treated products were devoid of complement-activating capacity, both when tested and ready-for-infusion and as heat-aggregated preparations. The chemically treated preparations showed atypical binding properties to Staphylococcal protein A. (2) The poly-(ethylene glycol) (PEG)-treated preparations and the untreated reference activated complement before and after heat-aggregation. (3) The albumin protected and the pH 4-treated product did not spontaneously activate complement in the ready-for-infusion state but did so after heat-aggregation. These results suggest that only the albumin-protected and the pH 4-treated products can be expected both to be well tolerated when given intravenously to high-risk agammaglobulinemic patients and to exhibit normal Fc functions in vivo.
对14种静脉注射用免疫球蛋白制剂进行了测试，以评估其Fc段的功能。研究了对补体溶血活性的抑制、C1q结合以及IgG亚类与葡萄球菌蛋白A的相互作用。对即溶制剂和热聚集制剂都进行了补体研究。可区分出三组产品：（1）经酶处理和化学处理的产品，无论是测试时、即溶状态还是热聚集制剂，均无补体激活能力。化学处理的制剂对葡萄球菌蛋白A表现出非典型结合特性。（2）聚乙二醇（PEG）处理的制剂和未处理的参考制剂在热聚集前后均激活补体。（3）白蛋白保护的产品和pH 4处理的产品在即溶状态下不会自发激活补体，但在热聚集后会激活。这些结果表明，只有白蛋白保护的产品和pH 4处理的产品有望在静脉注射给高危无丙种球蛋白血症患者时具有良好的耐受性，并在体内表现出正常的Fc功能。
