METHOD FOR OBTAINING PURIFIED, SAFE ANTIBODY PREPARATIONS FROM THE VIROLOGICAL POINT OF VIEW

摘要

1. A method of obtaining purified, virologically safe and virologically inactivated preparations of antibodies from a stock solution containing antibodies and impurities, the process comprising the following steps: (a) adjusting the pH of the stock solution to about 4.6-4.95, in particular to about 4.8-4.95 to obtain an intermediate solution; (b) adding caprylate and / or heptanoate ions to the intermediate solution while maintaining the pH at about 4.8-4.95, resulting in precipitate formation , with antibodies mainly about immediately present in the supernatant; (c) incubation of the supernatant solution under conditions including certain concentrations of caprylate and / or heptanoate ions, time, pH and temperature; optionally concentrating and diafiltrating the solution to adjust the pH; (d) applying a filtered solution using at least one anion-exchange resin at a pH of from about 5.0 to 5.2, and optionally, on two different anion-exchange resins under conditions ensuring the binding of contaminants with resin in the absence of significant binding of antibodies to the resin, to obtain purified, virologically safe and virologically inactivated antibody preparations. 2. The method according to claim 1, in which the second anion exchange chromatography is performed at a pH in the range from 6.7 to 6.9.3. The method of claim 1 and / or 2, wherein steps (b) and (c) are repeated at least once. The method of claim 3, wherein the stock solution contains antibodies obtained from plasma. The method according to claim 4, wherein in step (d) the inactivated solution is brought into contact with two different anion exchange resins