ArticleEuropean journal of hospital pharmacy : science and practice2017
Batch-to-batch N-glycosylation study of infliximab, trastuzumab and bevacizumab, and stability study of bevacizumab.
Article in European journal of hospital pharmacy : science and practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 36 citations in OpenAlex.
- Statistical Tools for Biosimilarity Assessment: A Perspective Based on WHO-recommended Approaches.The AAPS journal · 2026Article
- In-Membrane Enrichment and Peptic Digestion to Facilitate Analysis of Monoclonal Antibody Glycosylation.Analytical chemistry · 2024Article
- Influence of pneumatic transportation on the stability of monoclonal antibodies.Scientific reports · 2023Article
- In vivo deglycosylation of recombinant glycoproteins in tobacco BY-2 cells.Plant biotechnology journal · 2023Article
- Comprehensive N-Glycan Mapping using Parallel Reaction Monitoring LC-MS/MS.Pharmaceutical research · 2023Article
- Consistency of Product Quality for SB5, an Adalimumab Biosimilar.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Article
- Article
- Anticalin N- or C-Terminal on a Monoclonal Antibody Affects Both Production and In Vitro Functionality.Antibodies (Basel, Switzerland) · 2022Article
- The First WHO International Standard for Harmonizing the Biological Activity of Bevacizumab.Biomolecules · 2021Article
- Media on-demand: Continuous reconstitution of a chemically defined media directly from solids.Biotechnology and bioengineering · 2021Article
- Glycoengineering Chinese hamster ovary cells: a short history.Biochemical Society transactions · 2021Review
- Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Glycosylation of Therapeutic Proteins: A Critical Quality Attribute.Methods in molecular biology (Clifton, N.J.) · 2021Review
- The process defines the product: what really matters in biosimilar design and production?Rheumatology (Oxford, England) · 2017Review
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 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesInfliximab, trastuzumab and bevacizumab are among the most frequently prescribed therapeutic proteins, and like most other therapeutic proteins, are glycosylated. As differences in glycosylation may significantly change the safety and efficacy of therapeutic glycoproteins, it is extremely important to control N-glycosylation consistency. In the first part of this study, the batch-to-batch consistency of the N-glycosylation of infliximab, trastuzumab and bevacizumab was analysed. In the second part, the consistency of the N-glycosylation of bevacizumab stored in polycarbonate syringes (for off-label drug use) for 3 months was examined.
methodsN-glycans were (i) enzymatically released using peptide-N-glycosidase F, (ii) reduced, and (iii) analysed using hydrophilic interaction liquid chromatography coupled with high-resolution mass spectrometry. Mass spectrometry data were interpreted using principal component analysis combined with two-way analysis of variance and Tukey post hoc tests. The biological activity of infliximab and trastuzumab was examined using enzyme-linked immunosorbent assays.
resultsThe results of both studies make important contributions to the field of hospital pharmacy. All batches of the studied therapeutic glycoproteins (infliximab, trastuzumab and bevacizumab) varied considerably (especially in galactosylation), while the N-glycosylation of bevacizumab remained unchanged during 3-month storage.
conclusionsThreshold values for batch-to-batch N-glycosylation variations should be established and batch-to-batch glycosylation consistency should be regularly tested. In our study, samples with significantly different N-glycosylation profiles showed no significant variations in biological activity, suggesting that the differences are probably not therapeutically significant.
Indexed as
Identifiers
What OpenQuestion holds
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.