ArticlemAbs
Simultaneous monitoring of oxidation, deamidation, isomerization, and glycosylation of monoclonal antibodies by liquid chromatography-mass spectrometry method with ultrafast tryptic digestion.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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Who cites it
31 citing papers in PubMed, 88 citations in OpenAlex.
- Using mass spectrometry for robust identity release testing in a global quality control network.mAbs · 2026Article
- Glycosylation Profiles in Cardiovascular Diseases: A Bibliometric Analysis.Health data science · 2026Article
- Comparative study of trastuzumab modification analysis using mono/multi-epitope affinity technology with LC-QTOF-MS.Journal of pharmaceutical analysis · 2024Article
- Internal Fragments Enhance Middle-Down Mass Spectrometry Structural Characterization of Monoclonal Antibodies and Antibody-Drug Conjugates.Analytical chemistry · 2024Article
- Multi-Attribute Monitoring Method for Process Development of Engineered Antibody for Site-Specific Conjugation.Journal of the American Society for Mass Spectrometry · 2023Article
- Development of an icIEF assay for monitoring AAV capsid proteins and application to gene therapy products.Molecular therapy. Methods & clinical development · 2023Article
- Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing.Nature protocols · 2023Review
- Photodegradation of Rituximab and Critical Evaluation of Its Sensibility to Electromagnetic Radiation.AAPS PharmSciTech · 2022Article
- Standard-Free Absolute Quantitation of Antibody Deamidation Degradation and Host Cell Proteins by Coulometric Mass Spectrometry.Analytical chemistry · 2022Article
- Investigation of Tryptic Protein Digestion in Microdroplets and in Bulk Solution.Journal of the American Society for Mass Spectrometry · 2022Article
- Development of a comprehensive approach for performance evaluation of a quantitative multi-attribute method as a quality control method.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2022Article
- Process- and Product-Related Foulants in Virus Filtration.Bioengineering (Basel, Switzerland) · 2022Review
- Multi attribute method implementation using a High Resolution Mass Spectrometry platform: From sample preparation to batch analysis.PloS one · 2022Article
- Photo-Oxidation of Therapeutic Protein Formulations: From Radical Formation to Analytical Techniques.Pharmaceutics · 2021Review
- A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.ACS pharmacology & translational science · 2020Article
- Top-Down Characterization of an Intact Monoclonal Antibody Using Activated Ion Electron Transfer Dissociation.Analytical chemistry · 2020Article
- Current LC-MS-based strategies for characterization and quantification of antibody-drug conjugates.Journal of pharmaceutical analysis · 2020Review
- At-line high throughput site-specific glycan profiling using targeted mass spectrometry.Biotechnology reports (Amsterdam, Netherlands) · 2020Article
- Development of a novel, high-throughput screening tool for efficient perfusion-based cell culture process development.Biotechnology progress · 2019Article
- Effect of Chemical Oxidation on the Higher Order Structure, Stability, Aggregation, and Biological Function of Interferon Alpha-2a: Role of Local Structural Changes Detected by 2D NMR.Pharmaceutical research · 2018Article
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibodies are subjected to a wide variety of post-translational modifications (PTMs) that cause structural heterogeneity. Characterization and control of these modifications or quality attributes are critical to ensure antibody quality and to define any potential effects on the ultimate safety and potency of antibody therapeutics. The biopharmaceutical industry currently uses numerous tools to analyze these quality attributes individually, which requires substantial time and resources. Here, we report a simple and ultrafast bottom-up liquid chromatography-mass spectrometry (uLC-MS) method with 5 min tryptic digestion to simultaneously analyze multiple modifications, including oxidation, deamidation, isomerization, glycation, glycosylation, and N-terminal pyro-glutamate formation, which can occur during antibody production in mammalian cell culture, during purification and/or on storage. Compared to commonly used preparation procedures, this uLC-MS method eliminates assay artifacts of falsely-increased Met oxidation, Asp isomerization, and Asn deamidation, a problem associated with long digestion times in conventional LC-MS methods. This simple, low artifact multi-attribute uLC-MS method can be used to quickly and accurately analyze samples at any stage of antibody drug development, in particular for clone and media selection during cell culture development.
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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.