ArticlemAbs
A new tool for monoclonal antibody analysis: application of IdeS proteolysis in IgG domain-specific characterization.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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Who cites it
42 citing papers in PubMed, 143 citations in OpenAlex.
- Article
- Fab-Level LC-MS Assessment of Chain Pairing in Asymmetric Bispecific Antibodies Enabled by IdeS Digestion and Selective Hinge Reduction.Pharmaceutical research · 2026Article
- Applications of Matrix-Assisted Laser Desorption Ionization In-Source Decay Mass Spectrometry.Advances in experimental medicine and biology · 2026Review
- Gel Electrophoretic Detection of Black Market ACE-031.Drug testing and analysis · 2025Article
- Ultrafast Microdroplet Digestion of Antibodies with Fc-Silencing Mutations.Analytical chemistry · 2025Article
- Determination of the decapping efficiency of THIOMAB™ antibodies with the engineered cysteine in the Fc region for making antibody-drug conjugates by specific hinge fragmentation-liquid chromatography.Analytical and bioanalytical chemistry · 2025Article
- Dual formation mechanisms of acidic variants in cysteine-engineered antibodies and strategies for their reduction.Frontiers in bioengineering and biotechnology · 2025Article
- Enhanced N-Glycan Profiling of Therapeutic Monoclonal Antibodies through the Application of Upper-Hinge Middle-Up Level LC-HRMS Analysis.Antibodies (Basel, Switzerland) · 2024Article
- CE-MS/MS and CE-timsTOF to separate and characterize intramolecular disulfide bridges of monoclonal antibody subunits and their application for the assessment of subunit reduction protocols.Analytical and bioanalytical chemistry · 2024Article
- Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay.The AAPS journal · 2024Article
- Revealing charge heterogeneity of stressed trastuzumab at the subunit level.Analytical and bioanalytical chemistry · 2023Article
- Rapid Characterization of Antibodies via Automated Flow Injection Coupled with Online Microdroplet Reactions and Native-pH Mass Spectrometry.Analytical chemistry · 2023Article
- Impact of the conjugation of antibodies to the surfaces of polymer nanoparticles on the immune cell targeting abilities.Nano convergence · 2021Article
- Microdroplet Ultrafast Reactions Speed Antibody Characterization.Analytical chemistry · 2021Article
- Recognition of a highly conserved glycoprotein B epitope by a bivalent antibody neutralizing HCMV at a post-attachment step.PLoS pathogens · 2020Article
- Intact and middle-down CIEF of commercial therapeutic monoclonal antibody products under non-denaturing conditions.Electrophoresis · 2020Article
- At-line high throughput site-specific glycan profiling using targeted mass spectrometry.Biotechnology reports (Amsterdam, Netherlands) · 2020Article
- Novel Interface for High-Throughput Analysis of Biotherapeutics by Electrospray Mass Spectrometry.Analytical chemistry · 2020Article
- Capacitive Sensor to Monitor Enzyme Activity by Following Degradation of Macromolecules in Real Time.Applied biochemistry and biotechnology · 2019Article
- Impact of mammalian cell culture conditions on monoclonal antibody charge heterogeneity: an accessory monitoring tool for process development.Journal of industrial microbiology & biotechnology · 2019Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibody (mAb) products are extraordinarily heterogeneous due to the presence of a variety of enzymatic and chemical modifications, such as deamidation, isomerization, oxidation, glycosylation, glycation, and terminal cyclization. The modifications in different domains of the antibody molecule can result in different biological consequences. Therefore, characterization and routine monitoring of domain-specific modifications are essential to ensure the quality of the therapeutic antibody products. For this purpose, a rapid and informative methodology was developed to examine the heterogeneity of individual domains in mAb products. A recently discovered endopeptidase, IdeS, cleaves heavy chains below the hinge region, producing F(ab') 2 and Fc fragments. Following reduction of disulfide bonds, three antibody domains (LC, Fd, and Fc/2) can be released for further characterization. Subsequent analyses by liquid chromatography/mass spectrometry, capillary isoelectric focusing, and glycan mapping enable domain-specific profiling of oxidation, charge heterogeneity, and glycoform distribution. When coupled with reversed phase chromatography, the unique chromatographic profile of each molecule offers a simple strategy for an identity test, which is an important formal test for biopharmaceutical quality control purposes. This methodology is demonstrated for a number of IgGs of different subclasses (IgG1, IgG2, IgG4), as well as an Fc fusion protein. The presented technique provides a convenient platform approach for scientific and formal therapeutic mAb product characterization. It can also be applied in regulated drug substance batch release and stability testing of antibody and Fc fusion protein products, in particular for identity and routine monitoring of domain-specific modifications.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.