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US 12,000,811 B2Granted
Method and system of identifying and quantifying antibody fragmentation
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsYuetian Yan, Shunhai Wang
Life of this patent
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Abstract
Methods and system for identifying and quantifying antibody fragments and identifying the site of fragmentation on an antibody are provided herein.
Claims21
A method for quantification of a fragment of an antibody in a sample, said method comprising:
- contacting the sample to a chromatographic system having a mixed-mode size-exclusion chromatography resin with a charge-charge interaction functionality;
- washing the mixed-mode size-exclusion chromatography resin using a mobile phase to provide an eluent with the fragment;
- and
- quantifying the amount of the fragment of the antibody.
1 more element
A method for identifying a fragment of an antibody in a sample, said method comprising;
- contacting the sample to a chromatographic system having a mixed-mode size-exclusion chromatography resin with a charge-charge interaction functionality;
- washing the mixed-mode size-exclusion chromatography resin using a mobile phase to provide an eluent with the fragment;
- determining the molecular weight of the fragment in the eluent using a mass spectrometer, wherein the mass spectrometer is coupled to the chromatographic system;
- and
- correlating the molecular weight data of the fragment to data obtained from at least one known protein standard to identify said fragment of said antibody;
- wherein the fragment is a degradation product of the antibody or the fragment is a digestion product of the antibody.
3 more elements
A method for identifying a fragment of an antibody in a sample, said method comprising;
- contacting the sample to a chromatographic system having a mixed-mode size-exclusion chromatography resin with a charge-charge interaction functionality;
- washing the mixed-mode size-exclusion chromatography resin using a mobile phase to provide an eluent with the fragment;
- determining the molecular weight of the fragment in the eluent using a mass spectrometer, wherein the mass spectrometer is coupled to the chromatographic system;
- and
- correlating the molecular weight data of the fragment to data obtained from at least one known protein standard to identify said fragment of said antibody;
- wherein the mass spectrometer is a tandem mass spectrometer.
3 more elements
Dependencies are inferred from the claim text.