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本文就最近正在开发的两种利用单克隆抗体(McAb)亲和层析法高度纯化的因子Ⅷ制剂(Monoclate和AHF-M)的制备、特性及临床效果作了介绍。两种制剂纯化中所用的McAb及制剂的病毒灭活方法有较大差异。 Monoclate利用vW因子的McAb作亲和层析柱。取自血浆提取的冷沉淀,上亲和层析柱,洗净杂蛋白后,用高浓度的钙离子溶液将因子Ⅷ解离洗脱,再经氨基己基琼脂糖层析后透析、过滤、冻干,最后加热灭活病毒。 AHF-M则利用因子Ⅷ促凝成分(Ⅷ∶C)的McAb作亲和层析柱。从血浆中取得的冷沉淀,先经用有机溶剂/表面活性剂处理,以
This article describes the preparation, characterization, and clinical effects of two highly purified factor VIII preparations (Monoclate and AHF-M) that are being developed recently using monoclonal antibody (McAb) affinity chromatography. Two kinds of preparations used in the purification of McAbs and preparations of the virus inactivation methods are quite different. Monoclate utilizes vW factor McAbs as affinity columns. Taken from the cold precipitation of plasma extract, the affinity chromatography column, wash the complex protein, the factor VIII with high concentration of calcium ion solution elution, and then by amino-dextrose chromatography after dialysis, filtration, freezing Dry, and finally heat to inactivate the virus. AHF-M is the use of Factor VIII procoagulant component (VIII: C) McAb affinity chromatography column. The cryoprecipitate obtained from the plasma is first treated with an organic solvent / surfactant