公开(公告)号：US20070173638A1

公开(公告)日：2007-07-26

申请号：US10590900

申请日：2005-02-25

申请人： Andrea Buchacher ,  Gunther Iberer ,  Jurgen Romisch

发明人： Andrea Buchacher ,  Gunther Iberer ,  Jurgen Romisch

IPC分类号： C07K16/18

CPC分类号： C07K16/065 ,  A61L2/0011 ,  A61L2/0017 ,  A61L2/0023

摘要： A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starting solution comprising antibodies and contaminants, the method comprising the steps of: (a) adjusting the pH of the starting solution to about 4.6 to about 4.95 in particular to about 4.8 to about 4.95 to produce an intermediate solution; (b) adding caprylate and/or heptanoate ions to the intermediate solution and maintaining the pH at about 4.6 to about 4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate is formed and the antibodies are essentially present in the supernatant; (c) incubating the supernatant solution under conditions of caprylate and/or heptanoate ion concentration, time, pH and temperature optionally concentrating and diafiltrating the filtrated solution before pH adjustment; (d) applying the filtered solution with a least one anion exchange resin and optionally with two different anion exchange resins under conditions that allow binding of contaminants to the resin while not allowing significant binding' of the antibodies to the resin, wherein a purified, virus inactivated and virus safe antibody preparation is produced.

摘要翻译： 从包含抗体和污染物的起始溶液制备纯化的病毒灭活和病毒安全的抗体制剂的方法，所述方法包括以下步骤：（a）将起始溶液的pH调节至约4.6至约4.95，特别是约 4.8至约4.95以产生中间溶液; （b）向中间体溶液中加入辛酸酯和/或庚酸酯离子，并将pH保持在约4.6至约4.95，特别是约4.8至约4.95的pH，由此形成沉淀物，并且抗体基本上存在于上清液中; （c）在辛酸盐和/或庚酸盐离子浓度，时间，pH和温度条件下将上清液温育，任选地浓缩并在pH调节之前渗滤滤液; （d）在允许污染物与树脂结合的条件下使用至少一种阴离子交换树脂和任选地含有两种不同的阴离子交换树脂的过滤溶液，同时不允许抗体与树脂的显着结合，其中纯化的病毒 产生灭活和病毒安全的抗体制备。