Chemistry: natural resins or derivatives; peptides or proteins; – Proteins – i.e. – more than 100 amino acid residues – Blood proteins or globulins – e.g. – proteoglycans – platelet...
Reexamination Certificate
2005-02-25
2009-06-30
Saunders, David A (Department: 1644)
Chemistry: natural resins or derivatives; peptides or proteins;
Proteins, i.e., more than 100 amino acid residues
Blood proteins or globulins, e.g., proteoglycans, platelet...
C424S176100, C424S177100, C530S390500, C530S414000, C530S416000, C530S419000
Reexamination Certificate
active
07553938
ABSTRACT:
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.
REFERENCES:
patent: 6307028 (2001-10-01), Lebing et al.
patent: 7138120 (2006-11-01), Laursen et al.
patent: 2007/0244305 (2007-10-01), Parkkinen
patent: 0 374 625 (1990-06-01), None
patent: 0893450 (1999-01-01), None
patent: WO 2005/073252 (2005-08-01), None
Steinbuch, M et al., “Isolement de I'immunoglubuline lgG du plasma humain a I'aide de I'acide caprylique,” Rev. Franc. Etudes Clin. et Biol., vol. 14, 1969, pp. 1054-1058 (Abstr. Only Considered).
Lundblad, J. Let al., “Inactivation of Lipid-Enveloped Viruses in Proteins by Caprylate,” Vox Sanguinis, S karger AG, Basel, CH, vol. 60, No. 2, 1991, s. 75-81.
Lebing, W. et al., “Properties of a new intravenous immunoglobulin (IGIV-C, 10pc) produced by virus inactivation with caprylate and column chromatography,” Vox Sanguinis, vol. 84, 2003, pp. 193-201.
Trejo, S. R. et al., “Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process,” Vox Sanguinis, vol. 84, 2003, pp. 176-187.
Buchacher Andrea
Iberer Günther
Römisch Jürgen
Hobbs Ann S.
Kelley Matthew E.
Octapharma AG
Saunders David A
Venable LLP
LandOfFree
Method of providing a purified, virus safe antibody preparation does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method of providing a purified, virus safe antibody preparation, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method of providing a purified, virus safe antibody preparation will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4091315