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    • 6. 发明申请
    • Albumin solution and process for the production thereof
    • 白蛋白溶液及其生产方法
    • US20060234907A1
    • 2006-10-19
    • US10544833
    • 2004-02-13
    • Werner GehringerKatharina PockJürgen RömischTor-Einar SvaeChristoph Kannicht
    • Werner GehringerKatharina PockJürgen RömischTor-Einar SvaeChristoph Kannicht
    • C07K14/765
    • A61L2/0088C07K14/765
    • The invention relates to a therapeutically usable virus-inactivated albumin, and to a process for the preparation of a therapeutically usable virus-inactivated albumin, characterized by the combination of the following steps: (a) subjecting a first aqueous albumin solution to a treatment for virus inactivation by the SD method by contacting it with SD reagents at a temperature of below 45° C.; (b) removing, at least substantially, the SD reagents by oil extraction followed by hydrophobic interaction chromatography, wherein a hydrophobic matrix, especially a matrix to which hydrophobic groups may optionally be bound, is used for said chromatography, with the proviso that said groups are aliphatic groups with more than 24 carbon atoms, to obtain a second albumin solution to which (c) optionally one or more stabilizers selected from the group of sugars, amino acids and sugar alcohols are added, with the proviso that no indole stabilizer and no C6-C10 fatty acid is employed as said stabilizer, whereupon (d) said second albumin solution to which a stabilizer has optionally been added is subjected to final packaging and sterile filtration and optionally filled into final containers.
    • 本发明涉及治疗上可用的病毒灭活的白蛋白,以及制备治疗上可用的病毒灭活的白蛋白的方法,其特征在于以下步骤的组合:(a)使第一种含水白蛋白溶液进行治疗 通过SD方法通过在低于45℃的温度下与SD试剂接触来进行病毒灭活。 (b)通过油提取至少基本上除去SD试剂,然后通过疏水相互作用色谱法除去,其中疏水基质,特别是疏水基团可以任选地结合的基质用于所述层析,条件是所述基团 是具有超过24个碳原子的脂族基团,以获得第二白蛋白溶液,其中(c)任选地加入一种或多种选自糖,氨基酸和糖醇的稳定剂,条件是没有吲哚稳定剂和没有 使用C 6 -C 10脂肪酸作为所述稳定剂,然后(d)将任选加入稳定剂的所述第二白蛋白溶液进行最终包装并将其无菌 过滤并任选地填充到最终容器中。