Ion exchange chromatography of GLP-1, analogs and derivatives thereof
AssigneeNovo Nordisk A/S
InventorArne Staby
Life of this patent
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Abstract
The present invention relates to an ion exchange chromatography process for purifying GLP-1 or an analog or a derivative thereof from a mixture containing said GLP-1 and related impurities, and to an industrial method including such ion exchange chromatography process.
Claims9
A process for purifying a glucagon-like peptide 1 (GLP-1) from a mixture comprising said GLP-1 peptide and impurities, said method comprising:
- eluting said GLP-1 peptide and said impurities of said mixture from a cation exchange chromatography matrix using a solution comprising an organic modifier, water, optionally a salt component, and optionally a buffer, with a linear or step gradient or isocratically in salt component and/or with a linear or step pH-gradient or at a constant pH-value, wherein the pH-gradient or pH-value should be in the range where said GLP-1 peptide has a positive local or overall net charge different from the local or overall positive net charge of said impurities so as to remove said impurities.
A process for purifying a glucagon-like peptide 1 (GLP-1) from a mixture comprising said GLP-1 peptide and related impurities, said method comprising:
- eluting said GLP-1 peptide and said related impurities of said mixture from a cation exchange chromatography matrix using a solution consisting essentially of an organic modifier, water, optionally a salt component, and optionally a buffer, with a linear or step gradient or isocratically in salt component and/or with a linear or step pH-gradient or at a constant pH-value, wherein the pH-gradient or pH-value should be in the range where said GLP-1 peptide has a positive local or overall net charge different from the local or overall positive net charge of said related impurities so as to remove said related impurities.
A process for purifying a peptide selected from the group consisting of FactorVII, FactorVIIa, FactorVIIai, and D-Phe-Phe-Arg-FactorVIIa from a mixture comprising said peptide and related impurities, said method comprising:
- eluting said peptide and said related impurities of said mixture from a cation exchange chromatography matrix using a solution consisting essentially of an organic modifier, water, optionally a salt component, and optionally a buffer, with a linear or step gradient or isocratically in salt component and/or with a linear or step pH-gradient or at a constant pH-value, wherein the pH-gradient or pH-value should be in the range where said peptide has a positive local or overall net charge different from the local or overall positive net charge of said related impurities so as to remove said related impurities.
Dependencies are inferred from the claim text.