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PROCESS FOR MANUFACTURING HIGHLY PURITY FIBRINOGEN, HIGHLY HIGH PURITY FIBRINOGEN OBTAINED AND A PHARMACEUTICAL COMPOSITION CONTAINING SAME
PROCESS FOR MANUFACTURING HIGHLY PURITY FIBRINOGEN, HIGHLY HIGH PURITY FIBRINOGEN OBTAINED AND A PHARMACEUTICAL COMPOSITION CONTAINING SAME
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机译:制造高纯度纤维蛋白原,获得的高纯度纤维蛋白原和包含相同成分的药物组合物的方法
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摘要
The invention relates to a process for producing high purity fibrinogen. This method is characterized in that it comprises, from cryoprecipitate of blood plasma of animal or human origin, put in aqueous solution, the treatment of this solution to bring it to an ionic strength equal to that of a solution buffer having the following composition: BR/ (CF DRAWING IN BOPI) BR/ BR/ this adjusted ionic strength solution is passed over an anion exchange column comprising an exchange gel of anion, for example in the form of beads, based on crosslinked agarose comprising quaternary amine groups, in particular at the end of a small spacer arm, for example of the C 1 -C 6 alkylene type connected to the agarose beads, in particular to approximately 6% of agarose and elution is carried out with a first elution solution of the same ionic strength, these conditions making it possible to adsorb at least selectively fibrinogen to said column, which is desorbed by an elution solution higher ionic strength at 200 mM NaCl. BR/ A high purity fibrinogen is obtained. / P
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