Affinity chromatography-coupled native mass spectrometry for antibody analysis
AssigneeRegeneron Pharmaceuticals, Inc.
InventorShunhai Wang
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Abstract
The present invention provides rapid, sensitive high-throughput methods and systems for characterizing peptides or proteins using affinity-based chromatography-coupled native mass spectrometry to improve manufacturing process of biopharmaceutical products, such as identifying impurities during antibody purification, monitoring post-translational modification variants during production, or characterizing drug-to-antibody ratio of antibody-drug conjugates. The separation profiles of the peptides or proteins are generated and compared to identify or qualify the peptides or proteins, wherein the separation profile is based on differential affinity binding.
Claims19
A method for identifying at least one peptide or protein in a sample, comprising:
- contacting the sample to a solid surface, wherein the solid surface comprises an affinity-binding molecule of the at least one peptide or protein;
- washing the solid surface with a mobile phase to produce at least one eluant, wherein the mobile phase consists of an acidic mobile phase having a pH value of about pH 1.0-4.6, and wherein the eluant comprises the at least one peptide or protein in the acidic mobile phase;
- and
- providing the eluant to a mass spectrometer comprising an orbitrap mass analyzer operating under native conditions to characterize the at least one peptide or protein comprising low-abundance post-translational modifications in the at least one eluant.
Dependencies are inferred from the claim text.