STABLE LIQUID PHARMACEUTICAL FORMULATION OF IGG ANTIBODIES

Title:

STABLE LIQUID PHARMACEUTICAL FORMULATION OF IGG ANTIBODIES

Document Type and Number:

WIPO Patent Application WO2003039485

Kind Code:

A3

Abstract:

This invention is directed to a stable liquid pharmaceutical formulation comprising a high concentration, e.g. 50 mg/ml or more, of antibody in about 20-60 mM succinate buffer or 30-70 mM histidine buffer, having pH from about pH 5.5 to about pH 6.5, about 0.01-0.1 % polysorbate, and a tonicity modifier that contributes to the isotonicity of the formulation. This liquid formulation is stable at refrigerated temperature (2-8°C) for at least 1 year, and preferably 2 years. This liquid formulation is suitable for subcutaneous injection. This invention is exemplified by Daclizumab, a humanized anti-IL-2 receptor monoclonal antibody; HAIL-12, a humanized anti-IL-12 monoclonal antibody; HuEP5C7, a humanized anti-L selectin monoclonal antibody; and Flintozumab, a humanized anti-gamma interferon monoclonal antibody.

Inventors:

KAISHEVA ELIZABET A (US)
GUPTA SUPRIYA (US)
DUVUR SHANTI G (US)
SUBRAMANIAN MALATHY (US)

Application Number:

PCT/US2002/036093

Publication Date:

February 12, 2004

Filing Date:

November 08, 2002

Export Citation:

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Assignee:

PROTEIN DESIGN LABS (US)
KAISHEVA ELIZABET A (US)
GUPTA SUPRIYA (US)
DUVUR SHANTI G (US)
SUBRAMANIAN MALATHY (US)

International Classes:

A61K47/08; A61K9/00; A61K9/08; A61K39/395; A61K47/02; A61K47/12; A61K47/34; A61P37/06; C07K16/24; C07K16/28; A61K47/26; (IPC1-7): A01N37/18; A61K38/00; C07K16/00

Domestic Patent References:

WO1998022136A2	1998-05-28
WO1998056418A1	1998-12-17
WO1997045140A1	1997-12-04
WO2002030463A2	2002-04-18

Foreign References:

US6267958B1

2001-07-31

Other References: