Ng P K, Eguizabal H C, Mitra G
Thromb Res. 1986 Jun 15;42(6):825-34. doi: 10.1016/0049-3848(86)90119-2.
An improved process for producing high purity Factor VIII concentrate has been developed. The improvement was based on the combination of three precipitating agents (polyethylene glycol, glycine and sodium chloride) which heretofore have been used alone in a single step or in separate and distinct steps in a multi-step process. The product was pasteurized in solution (60 degrees C, 10 hrs) to reduce possible risks of virus transmission. The purified product has significantly higher specific activity and lower fibrinogen and immunoglobulin levels when compared to other commercial concentrates.
已开发出一种生产高纯度凝血因子VIII浓缩物的改进工艺。该改进基于三种沉淀剂（聚乙二醇、甘氨酸和氯化钠）的组合，此前这些沉淀剂在单步中单独使用，或在多步工艺中以单独且不同的步骤使用。产品在溶液中进行巴氏消毒（60摄氏度，10小时）以降低病毒传播的潜在风险。与其他商业浓缩物相比，纯化后的产品具有显著更高的比活性以及更低的纤维蛋白原和免疫球蛋白水平。
