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PROCEDE DE REALISATION D'UNE PREPARATION ANTICORPS AVIRALE PURIFIEE
专利权人:
OCTAPHARMA AG
发明人:
BUCHACHER, ANDREA,IBERER, GUENTHER,ROEMISCH, JUERGEN
申请号:
CA2557229
公开号:
CA2557229C
申请日:
2005.02.25
申请国别(地区):
CA
年份:
2012
代理人:
摘要:
A method of preparing a purified, virus inactivated and virus safe antibodypreparation from a starting solution comprising antibodies and contaminants,the method comprising the steps of: (a) adjusting the pH of the startingsolution to about 4.6 to about 4.95 in particular to about 4.8 to about 4.95to produce an intermediate solution; (b) adding caprylate and/or heptanoateions to the intermediate solution and maintaining the pH at about 4.6 to about4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate isformed and the antibodies are essentially present in the supernatant; (c)incubating the supernatant solution under conditions of caprylate and/orheptanoate ion concentration, time, pH and temperature optionallyconcentrating and diafiltrating the filtrated solution before pH adjustment;(d) applying the filtered solution with a least one anion exchange resin andoptionally with two different anion exchange resins under conditions thatallow binding of contaminants to the resin while not allowing significantbinding' of the antibodies to the resin, wherein a purified, virus inactivatedand virus safe antibody preparation is produced.
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