| 摘要 |
A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starling 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 caprylale and/or heplanoale 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 supematant solution under conditions of caprylale and/or heplanoale ion concentration, lime, 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 exchanae 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. |
