D’Atri et al., 2017 - Google Patents
Hydrophilic interaction chromatography hyphenated with mass spectrometry: a powerful analytical tool for the comparison of originator and biosimilar therapeutic …D’Atri et al., 2017
- Document ID
- 587325719872530875
- Author
- D’Atri V
- Fekete S
- Beck A
- Lauber M
- Guillarme D
- Publication year
- Publication venue
- Analytical chemistry
External Links
Snippet
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically …
- 108010045030 monoclonal antibodies 0 title abstract description 136
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by the preceding groups
- G01N33/48—Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6842—Proteomic analysis of subsets of protein mixtures with reduced complexity, e.g. membrane proteins, phosphoproteins, organelle proteins
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by the preceding groups
- G01N33/48—Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by the preceding groups
- G01N33/48—Investigating or analysing materials by specific methods not covered by the preceding groups biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/62—Detectors specially adapted therefor
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/86—Signal analysis
- G01N30/8665—Signal analysis for calibrating the measuring apparatus
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2500/00—Screening for compounds of potential therapeutic value
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
Similar Documents
Publication | Publication Date | Title |
---|---|---|
D’Atri et al. | Hydrophilic interaction chromatography hyphenated with mass spectrometry: a powerful analytical tool for the comparison of originator and biosimilar therapeutic monoclonal antibodies at the middle-up level of analysis | |
Füssl et al. | Comparative elucidation of cetuximab heterogeneity on the intact protein level by cation exchange chromatography and capillary electrophoresis coupled to mass spectrometry | |
Fekete et al. | Chromatographic, electrophoretic, and mass spectrometric methods for the analytical characterization of protein biopharmaceuticals | |
Füssl et al. | Charge variant analysis of monoclonal antibodies using direct coupled pH gradient cation exchange chromatography to high-resolution native mass spectrometry | |
Bults et al. | LC-MS/MS-based monitoring of in vivo protein biotransformation: quantitative determination of trastuzumab and its deamidation products in human plasma | |
Wei et al. | Native hydrophobic interaction chromatography hyphenated to mass spectrometry for characterization of monoclonal antibody minor variants | |
Beck et al. | Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry | |
Gstöttner et al. | Fast and automated characterization of antibody variants with 4D HPLC/MS | |
Zhang et al. | Identification and characterization of buried unpaired cysteines in a recombinant monoclonal IgG1 antibody | |
Beyer et al. | Microheterogeneity of recombinant antibodies: analytics and functional impact | |
Shah et al. | LC-MS/MS peptide mapping with automated data processing for routine profiling of N-glycans in immunoglobulins | |
Wang et al. | Application of a quantitative LC–MS multiattribute method for monitoring site-specific glycan heterogeneity on a monoclonal antibody containing two N-linked glycosylation sites | |
Maeda et al. | Analysis of nonhuman N-glycans as the minor constituents in recombinant monoclonal antibody pharmaceuticals | |
Camperi et al. | Fast and automated characterization of monoclonal antibody minor variants from cell cultures by combined protein-A and multidimensional LC/MS methodologies | |
Sokolowska et al. | Implementation of a high-resolution liquid chromatography–mass spectrometry method in quality control laboratories for release and stability testing of a commercial antibody product | |
Dai et al. | A middle-up approach with online capillary isoelectric focusing/mass spectrometry for in-depth characterization of Cetuximab charge heterogeneity | |
Gahoual et al. | Detailed characterization of monoclonal antibody receptor interaction using affinity liquid chromatography hyphenated to native mass spectrometry | |
Chumsae et al. | Identification and localization of unpaired cysteine residues in monoclonal antibodies by fluorescence labeling and mass spectrometry | |
Camperi et al. | Development of a 3D-LC/MS workflow for fast, automated, and effective characterization of glycosylation patterns of biotherapeutic products | |
Srzentić et al. | Advantages of extended bottom-up proteomics using Sap9 for analysis of monoclonal antibodies | |
Yu et al. | Accurate determination of succinimide degradation products using high fidelity trypsin digestion peptide map analysis | |
Jakes et al. | Tracking the behavior of monoclonal antibody product quality attributes using a multi-attribute method workflow | |
Neill et al. | Characterization of recombinant monoclonal antibody charge variants using OFFGEL fractionation, weak anion exchange chromatography, and mass spectrometry | |
Peng et al. | Chemical structure and composition of major glycans covalently linked to therapeutic monoclonal antibodies by middle-down nuclear magnetic resonance | |
Regl et al. | A generic HPLC method for absolute quantification of oxidation in monoclonal antibodies and Fc-fusion proteins using UV and MS detection |