ArticleJournal of pharmaceutical analysis2020
Comparing different domains of analysis for the characterisation of N-glycans on monoclonal antibodies.
Article in Journal of pharmaceutical analysis, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 43 citations in OpenAlex.
- Establishment of an N-Glycan Profiling Method for Three ERT Enzymes Used in Gaucher Disease Therapy.Molecules (Basel, Switzerland) · 2026Article
- A Multi-Laboratory, Multi-Platform Analysis of the Multi-Attribute Method.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Hydrophilic Interaction Chromatography HRMS with Acrylamide Monolithic Columns: A Novel Approach for Intact Antibody Glycoform Characterization.Analytical chemistry · 2025Article
- "Small is beautiful" - Examining reliable determination of low-abundant therapeutic antibody glycovariants.Journal of pharmaceutical analysis · 2024Article
- Comprehensive Analysis of Cetuximab Critical Quality Attributes: Impact of Handling on Antigen-Antibody Binding.Pharmaceutics · 2024Article
- Enhanced N-Glycan Profiling of Therapeutic Monoclonal Antibodies through the Application of Upper-Hinge Middle-Up Level LC-HRMS Analysis.Antibodies (Basel, Switzerland) · 2024Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- In-Membrane Enrichment and Peptic Digestion to Facilitate Analysis of Monoclonal Antibody Glycosylation.Analytical chemistry · 2024Article
- Comprehensive N-Glycan Mapping using Parallel Reaction Monitoring LC-MS/MS.Pharmaceutical research · 2023Article
- Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.Biotechnology and bioengineering · 2022Review
- Comprehensive Analysis of Nivolumab, A Therapeutic Anti-Pd-1 Monoclonal Antibody: Impact of Handling and Stress.Pharmaceutics · 2022Article
- Direct-MS analysis of antibody-antigen complexes.Proteomics · 2021Article
- Rapid Analysis of Biotherapeutics Using Protein A Chromatography Coupled to Orbitrap Mass Spectrometry.Analytical chemistry · 2021Article
- Development and validation of a platform reduced intact mass method for process monitoring of monoclonal antibody glycosylation during routine manufacturing.Bioengineered · 2020Article
- Immunoglobulin G Glycoprofiles are Unaffected by Common Bottom-Up Sample Processing.Journal of proteome research · 2020Article
- Recent progress in the molecular imaging of therapeutic monoclonal antibodies.Journal of pharmaceutical analysis · 2020Review
- Synthesis and Biological Evaluation of Antibody Drug Conjugates Based on an Antibody Expression System: Conamax.ACS omega · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
With the size of the biopharmaceutical market exponentially increasing, there is an aligned growth in the importance of data-rich analyses, not only to assess drug product safety but also to assist drug development driven by the deeper understanding of structure/function relationships. In monoclonal antibodies, many functions are regulated by N-glycans present in the constant region of the heavy chains and their mechanisms of action are not completely known. The importance of their function focuses analytical research efforts on the development of robust, accurate and fast methods to support drug development and quality control. Released N-glycan analysis is considered as the gold standard for glycosylation characterisation; however, it is not the only method for quantitative analysis of glycoform heterogeneity. In this study, ten different analytical workflows for N-glycan analysis were compared using four monoclonal antibodies. While observing good comparability between the quantitative results generated, it was possible to appreciate the advantages and disadvantages of each technique and to summarise all the observations to guide the choice of the most appropriate analytical workflow according to application and the desired depth of data generated.
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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.