| 摘要 |
An IgG containing fraction obtainable by 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 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. |
