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Process for the preparation of a von Willebrand (FvW) factor concentrate by chromatography and a FvW concentrate thus obtainable

机译:通过色谱法制备von Willebrand(FvW)因子浓缩物的方法和由此获得的FvW浓缩物

摘要

This invention relates to a process for the preparation of a very high purity von Willebrand factor concentrate from a biological fraction containing von Willebrand factor, including a separation by anion exchange chromatography using a vinyl polymer support of weak base type, the said separation comprising the steps of loading of the chromatographic support with the fraction containing von Willebrand factor, previously equilibrated with a suitable buffer, with a predetermined flowrate allowing the retention of the von Willebrand factor, washing of the support with an acidic buffer with a flowrate higher than the flowrate of the step a) until the not-retained proteins and the contaminants are removed, flushing and equilibrating of the chromatographic support with the buffer and using the flowrate of the step a), and elution of the von Willebrand factor by increasing of the ionic strength of the step c). The invention also relates to a von Willebrand factor concentrate for therapeutic use likely to be obtained by implementing of the process wherein the rate of Factor VIII:C/FvW:RCo is less than 0.06%.
机译:本发明涉及从含有冯·威勒布兰德因子的生物级分制备非常高纯度的冯·威勒布兰德因子浓缩物的方法,包括使用弱碱型乙烯基聚合物载体通过阴离子交换色谱法分离,所述分离包括以下步骤用预先用合适的缓冲液平衡过的含有von Willebrand因子的馏分上载有预定流速的色谱支持物进行色谱分离的方法,用酸性缓冲液洗涤支持物,流速高于步骤a)直到除去未保留的蛋白质和污染物,然后用缓冲液冲洗并平衡色谱支持物,并使用步骤a)的流速,然后通过增加离子强度来洗脱von Willebrand因子步骤c)。本发明还涉及可能通过实施其中因子VIII:C / FvW:RCo的比率小于0.06%的方法获得的用于治疗用途的von Willebrand因子浓缩物。

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