ArticlePharmaceutical research2024
Benchmark Glycan Profile of Therapeutic Monoclonal Antibodies Produced by Mammalian Cell Expression Systems.
Article in Pharmaceutical research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
What it found
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The trial behind it
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
27 citing papers in PubMed, 33 citations in OpenAlex.
- Article
- Operationalizing digital twins in biomanufacturing through interoperable process analytical technology.Bioprocess and biosystems engineering · 2026Article
- Native Top-Down Mass Spectrometry Combined with High-Resolution Charge Variant Analysis of Trastuzumab Originator and Biosimilars.Journal of the American Society for Mass Spectrometry · 2026Article
- Selective clearance of monoclonal antibodies via the mannose receptor is dependent on glycan pairing.Scientific reports · 2026Article
- Glycan Profiles of FDA-Approved Therapeutic Antibodies: Insights from Regulatory Submissions.The AAPS journal · 2026Article
- Robustness Evaluation of a Legacy N-Glycan Profiling Method for a Therapeutic Antibody Under ICH Q14 Lifecycle Principles.Antibodies (Basel, Switzerland) · 2026Article
- Industry-defined opportunities for advancing big data capabilities in biopharmaceutical manufacturing.Frontiers in bioengineering and biotechnology · 2026Review
- Glycan Remodeling Technologies for Enhancing Antibody Function.Advances in experimental medicine and biology · 2026Review
- Article
- CRISPR/Cas9-Mediated Knockouts of the ALG3 and GNTI in N. benthamiana and Their Application to Pharmaceutical Production.Plant biotechnology journal · 2025Article
- Article
- IgE based therapeutics are an emerging modality in cancer treatment.Discover oncology · 2025Review
- Structural and Functional Characterization of Anti-SARS-CoV-2 Spike Monoclonal Antibodies Produced via Bicistronic Expression in CHO Cells.Antibodies (Basel, Switzerland) · 2025Article
- Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Spotlight on Glycan Pairing: The Generation and Impact of Monoclonal Antibody Asymmetrical Fc N‑Glycan Pairs on Fc Receptor Interaction.ACS pharmacology & translational science · 2025Article
- NIST Biomanufacturing Reference Materials: Development, Applications, and Impact.Bridge (Washington, D.C. : 1969) · 2025Article
- Antibody Purification Using Spy Chemistry.Bio-protocol · 2025Article
- Fc gamma receptor polymorphisms in antibody therapy: implications for bioassay development to enhance product quality.Antibody therapeutics · 2025Review
- Enhancing monoclonal antibody production efficiency using CHO-MK cells and specific media in a conventional fed-batch culture.Cytotechnology · 2025Article
- Cracking the diversity of sweet drugs.Nature chemical biology · 2024Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aims to establish a benchmark glycan profile for commercial therapeutic monoclonal antibodies (mAbs) approved by the US Food and Drug Administration (FDA).
methodsWe conducted a rigorous comparison of glycosylation data from the regulatory submissions for FDA-approved therapeutic antibodies up to May 2023. This analysis includes over 150 mAbs produced by various mammalian cell expression systems.
resultsThe study identified nine prevalent glycan epitopes across all FDA-approved monoclonal antibodies produced by different expression systems. These epitopes include terminal N-acetylglucosamine, core fucose, terminal galactose, high mannose, α-galactose, terminal α2,3-linked N-acetylneuraminic acid, terminal α2,6-linked N-glycolylneuraminic acid, triantennary structure, and bisecting N-acetylglucosamine, thus establishing a benchmark glycan profile.
conclusionsThe findings of this study have significant implications for therapeutic antibody development, quality control, and regulatory compliance. The benchmark glycan profile enables the assessment of glycosylation consistency and comparability across a diverse range of antibody products, ensuring improved product quality within the biopharmaceutical industry.
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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.