Chemistry: molecular biology and microbiology – Animal cell – per se ; composition thereof; process of... – Method of culturing cells in suspension
Reexamination Certificate
2005-10-18
2005-10-18
Mosher, Mary E. (Department: 1648)
Chemistry: molecular biology and microbiology
Animal cell, per se ; composition thereof; process of...
Method of culturing cells in suspension
C435S390000, C435S412000, C435S413000, C435S417000, C435S418000, C435S419000
Reexamination Certificate
active
06955917
ABSTRACT:
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. The resin columns used to obtain a high yield of IgG retain IgM and IgA. IgA and IgM may be eluted from these resins in high yield and purity.
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Alred Patricia
Cook Scott A.
Lebing Wytold R.
Lee Douglas C.
Paul Hanns-Ingolf
Bayer Healthcare LLC
Mosher Mary E.
Womble Carlyle Sandridge & Rice PLLC
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