Invention Grant
- Patent Title: Process for the industrial-scale purification of gamma globulins from human plasma for industrial applications
- Patent Title (中): 工业级用于等离子体工业级纯化γ-球蛋白的工艺
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Application No.: US13519368Application Date: 2010-12-28
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Publication No.: US08933204B2Publication Date: 2015-01-13
- Inventor: Claudia Nardini , Andrea Morelli , Claudio Farina , Sabrina Esposito , Alessandra Lazzarotti , Arianna Petrucci
- Applicant: Claudia Nardini , Andrea Morelli , Claudio Farina , Sabrina Esposito , Alessandra Lazzarotti , Arianna Petrucci
- Applicant Address: IT Barga
- Assignee: Kedrion S.p.A.
- Current Assignee: Kedrion S.p.A.
- Current Assignee Address: IT Barga
- Agency: Abelman, Frayne & Schwab
- Priority: ITFI2009A0273 20091228
- International Application: PCT/IB2010/056093 WO 20101228
- International Announcement: WO2011/080698 WO 20110707
- Main IPC: A23J1/00
- IPC: A23J1/00 ; C07K1/00 ; C07K14/00 ; C07K17/00 ; C07K16/06 ; C07K1/18 ; C07K1/34

Abstract:
The invention relates to a novel, industrial-scale process for the purification of gamma-immunoglobulins (IgG) starting from plasma or fractions thereof. The method involves two chromatographic steps, i.e. a cation exchange capture chromatography, and then a polishing anion exchange chromatography, ensuring a highly purified end product, which contains no aggregates, and high yields. The process also involves a virus inactivation step by means of a solvent/detergent treatment to inactivate the viruses with a lipid envelope, and a virus removal step by nanofiltering to ensure the removal of the non-enveloped viruses.
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