Microchip capillary electrophoresis assays and reagents
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsTimothy Riehlman, Gabriel Carreau, Jeffrey Schneiderheinze, Nicole M. Nall
Life of this patent
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Abstract
MCE assays and reagents to assess purity and to identify impurities in protein drug product samples are provided. Methods for analyzing analytes in a protein drug sample are provided.
Claims20
An aqueous microchip capillary electrophoresis sample buffer for a protein drug sample, the buffer comprising:
- 155 to 200 mM 2-iodoacetamide;
- 0.50 to 1.5% lithium dodecyl sulfate;
- and
- 60 to 95 mM sodium phosphate,
- wherein the aqueous microchip capillary electrophoresis sample buffer has a pH of less than 8, and wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
An aqueous microchip capillary electrophoresis sample buffer for a protein drug sample, the buffer consisting of:
- 200 mM 2-iodoacetamide,
- 1.2% lithium dodecyl sulfate, and
- 60 mM Sodium phosphate,
- wherein the aqueous microchip capillary electrophoresis sample buffer has a pH of 6.0, and wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
An aqueous microchip capillary electrophoresis sample buffer for a protein drug sample, the buffer comprising:
- 0.50 to 1.5% lithium dodecyl sulfate,
- 45 to 75 mM sodium phosphate, and
- a reducing agent,
- wherein the aqueous microchip capillary electrophoresis sample buffer has a pH 9, and wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
An aqueous microchip capillary electrophoresis sample buffer, consisting of:
- 1.2% lithium dodecyl sulfate,
- 60 mM sodium phosphate, and
- 80 mM dithiothreitol,
- wherein the aqueous microchip capillary electrophoresis sample buffer has a pH of
- 9.0, and wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
An aqueous microchip capillary electrophoresis sample buffer for a protein drug sample, the buffer comprising:
- 0.05 to 0.75% lithium dodecyl sulfate,
- 5 mM to 115 mM NaCl,
- 5 mM to 85 mM HEPES, and
- 35 to 50 mM dithiothreitol,
- wherein the aqueous electrophoresis sample buffer has a pH greater than 8.0, and wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
An aqueous microchip capillary electrophoresis sample buffer for a protein drug sample, the buffer comprising:
- 0.28% lithium dodecyl sulfate,
- 41.5 mM NaCl,
- 13.8 mM HEPES, and
- 42.5 mM dithiothreitol,
- wherein the aqueous electrophoresis sample buffer has a pH greater than 8.0, and
- wherein microchip capillary electrophoresis is used to identify contaminants in the protein drug sample.
Dependencies are inferred from the claim text.