C - Chemistry – Metallurgy – 07 – K
Patent
C - Chemistry, Metallurgy
07
K
C07K 16/00 (2006.01) A61K 39/395 (2006.01) C07K 16/06 (2006.01) C07K 1/18 (2006.01) C07K 1/30 (2006.01) C07K 1/36 (2006.01)
Patent
CA 2676074
An improved process for the purification of antibodies from human plasma or other sources is disclosed. The process involves suspension of the antibodies at pH 3.8 to 4.5 followed by addition of caprylic acid and a pH shift to pH 5.0 to 5.2. A precipitate of contaminating proteins, lipids and caprylate forms and is removed, while the majority of the antibodies remain in solution. Sodium caprylate is again added to a final concentration of not less than about 15 mM. This solution is incubated for 1 hour at 25°C to effect viral inactivation. A precipitate (mainly caprylate) is removed and the clear solution is diluted with purified water to reduce ionic strength. Anion exchange chromatography using two different resins is utilized to obtain an exceptionally pure IgG with subclass distribution similar to the starting distribution. The method maximizes yield and produces a gamma globulin with greater than 99% purity.
Alred Patricia
Lebing Wytold R.
Lee Doug C.
Paul Hanss-Ingolf
Corporation Bayer
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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