Stabilized aqueous alpha-galactosidase composition and methods relating thereto
AssigneeRoche Diagnostics Operations, Inc.
InventorsHarald Sobek, Manfred Schmidt, Rainer Mueller, Werner Hoelke, Johann-Peter Thalhofer
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Abstract
The present invention provides an aqueous composition comprising a protein with enzymatic activity of alpha-galactosidase. The present invention further provides a method of stabilizing an aqueous composition comprising a protein with enzymatic activity of alpha-galactosidase, and a method of preparing a purified aqueous composition comprising the protein with enzymatic activity of alpha-galactosidase.
Claims28
An aqueous composition comprising a protein with enzymatic activity of alpha-galactosidase, the composition further comprising arginine at a concentration of above 100 mM, wherein the composition has a conductivity of at most 40 mS/cm.
A method of stabilizing an aqueous composition comprising a protein with enzymatic activity of alpha-galactosidase, the method comprising the steps of adding arginine to the composition to a final concentration of above 100 mM and maintaining conductivity of the composition to at most 40 mS/cm.
A method of preparing a purified aqueous composition comprising a protein with enzymatic activity of alpha-galactosidase and having a conductivity of at most 40 mS/cm, the method comprising the steps of
- providing a composition containing the protein,
- concentrating the composition in the presence of arginine to an arginine concentration of above 100 mM, and
- purifying the concentrated composition via cation exchange chromatography.
Dependencies are inferred from the claim text.