Pegylated g-csf polypeptides and methods of producing same

a technology of gcsf and polypeptides, which is applied in the direction of peptide/protein ingredients, immune disorders, extracellular fluid disorders, etc., can solve the problems of insufficient uniformity of peg moieties bound to groups other than those intended, complex characterization of such proteins, and inability to meet the requirements of characterization, etc., to achieve the effect of increasing the stability and uniformity of a pegylated polypeptid
US20070014762A1Inactive Publication Date: 2007-01-18MAXYGEN HLDG
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Patent Information

Authority / Receiving Office
US · United States
Patent Type
Applications(United States)
Current Assignee / Owner
MAXYGEN HLDG
Publication Date
2007-01-18
Estimated Expiration
Not applicable · inactive patent

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Abstract

A method for increasing the stability and uniformity of a PEGylated G-CSF polypeptide having at least one PEG moiety attached to the epsilon amino group of a lysine residue or the N-terminal amino group and at least one PEG moiety attached to a hydroxyl group, comprising subjecting the polypeptide to an elevated pH of above 8.0 for a period of time suitable to remove PEG moieties attached to a hydroxyl group, and reducing the pH to about 8.0 or lower; as well as PEGylated G-CSF polypeptides and compositions produced according to the method and methods for increasing neutrophil levels in a patient using the PEGylated G-CSF polypeptides and compositions.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Pursuant to 35 U.S.C. §119(e), this application claims the benefit of U.S. Provisional Application Ser. No. 60 / 686,726 filed on Jun. 1, 2005, the disclosure of which is incorporated by reference herein in its entirety for all purposes.FIELD OF THE INVENTION

[0002] The present invention relates to a method for removing labile PEG moieties from PEGylated G-CSF proteins to increase stability and uniformity, and to the resulting PEGylated G-CSF proteins. The invention also relates to pharmaceutical compositions comprising the PEGylated proteins and methods of treatment by administering the pharmaceutical compositions. BACKGROUND OF THE INVENTION

[0003] The covalent attachment of polyethylene glycol (PEG) moieties to proteins or polypeptides (“PEGylation”) is a well-known technique for improving the properties of such proteins or polypeptides, in particular pharmaceutical proteins, e.g. in order to improve circulation half-life and / or to shi...

Claims

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