ReviewFrontiers in molecular biosciences2022
Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.
Review in Frontiers in molecular biosciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
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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
10 citing papers in PubMed.
- Evaluation of TIMS-derived peptide mobility measurements: calibration strategy and MS1/MS2 discrepancies.Analytical and bioanalytical chemistry · 2026Article
- Recent Advances in Atomic-Resolution NMR Investigations of Monoclonal Antibodies.Biomolecules · 2026Review
- Process development for production of non-originator NISTmAb from CHO and NS0 cell lines.mAbs · 2025Article
- Assessment of ADC Higher Order Structure Through 2D NMR Analysis.Molecules (Basel, Switzerland) · 2025Article
- NIST Biomanufacturing Reference Materials: Development, Applications, and Impact.Bridge (Washington, D.C. : 1969) · 2025Article
- Comparison of N-Glycopeptide to Released N-Glycan Abundances and the Influence of Glycopeptide Mass and Charge States on N-Linked Glycosylation of IgG Antibodies.Journal of proteome research · 2024Article
- Top-down proteomics.Nature reviews. Methods primers · 2024Article
- Comprehensive multi-attribute method workflow for biotherapeutic characterization and current good manufacturing practices testing.Nature protocols · 2023Review
- 2D NMR Analysis as a Sensitive Tool for Evaluating the Higher-Order Structural Integrity of Monoclonal Antibody against COVID-19.Pharmaceutics · 2022Article
- NS0 and CHO cell lines generate distinct quality profiles for non-originator NISTmAbs.Biotechnology progressArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biopharmaceuticals such as monoclonal antibodies are required to be rigorously characterized using a wide range of analytical methods. Various material properties must be characterized and well controlled to assure that clinically relevant features and critical quality attributes are maintained. A thorough understanding of analytical method performance metrics, particularly emerging methods designed to address measurement gaps, is required to assure methods are appropriate for their intended use in assuring drug safety, stability, and functional activity. To this end, a series of interlaboratory studies have been conducted using NISTmAb, a biopharmaceutical-representative and publicly available monoclonal antibody test material, to report on state-of-the-art method performance, harmonize best practices, and inform on potential gaps in the analytical measurement infrastructure. Reported here is a summary of the study designs, results, and future perspectives revealed from these interlaboratory studies which focused on primary structure, post-translational modifications, and higher order structure measurements currently employed during biopharmaceutical development.
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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.