ReviewPharmaceuticals (Basel, Switzerland)2023
Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies.
Review in Pharmaceuticals (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 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
28 citing papers in PubMed.
- Resolving charge and glycosylation variants of cetuximab combining offline ion-exchange and hydrophilic interaction chromatography-HRMS.Analytical and bioanalytical chemistry · 2026Article
- Regulatory Definitions and Classification of Biosimilar Medications Across the 6 Regions of the World Health Organization: A Scoping Review.JAMA health forum · 2026Article
- Current GMP standards for the large-scale production of monoclonal antibodies.Bioengineering & translational medicine · 2026Review
- Parallel Sequencing of the Two Arms on a Bispecific Antibody by Electron Capture Dissociation on a timsOmni Platform Reveals Several By-products in the Controlled Fab-arm Exchange Process.Analytical chemistry · 2026Article
- Unlabeled NMR Approach with Site-Specific Methyl Assignments for Structural Evaluation of the IgG1 Fc Region.Journal of the American Chemical Society · 2026Article
- Multiple Heart-Cut Ion-Exchange Chromatography-Reversed-Phase Liquid Chromatography Platform for Online Desalting and Fractionation of Monoclonal Antibody Charge Variants.Journal of separation science · 2026Article
- Post-Translational Modifications in Protein Therapeutics: Importance and Analytical Tools.Methods in molecular biology (Clifton, N.J.) · 2026Review
- Biopharmaceutical analysis - current analytical challenges, limitations, and perspectives.Analytical and bioanalytical chemistry · 2026Review
- Real-time and label-free monitoring of monoclonal antibody secretion rates using a PC-TIR biosensor.Biosensors & bioelectronics · 2025Article
- Achieving Acceleration to First-in-Human: MSD's Learnings on Platform Method Validation Strategy.mAbs · 2025Article
- Review
- Article
- Structural and Functional Characterization of Anti-SARS-CoV-2 Spike Monoclonal Antibodies Produced via Bicistronic Expression in CHO Cells.Antibodies (Basel, Switzerland) · 2025Article
- The role of multi-omics in biomarker discovery, diagnosis, prognosis, and therapeutic monitoring of tissue repair and regeneration processes.Journal of orthopaedic translation · 2025Review
- Article
- Current advances in separation chemistry for antibody purification and analysis.Analytical sciences : the international journal of the Japan Society for Analytical Chemistry · 2025Review
- Optimization and Validation of the Cationization Method for the Fab' Fragment of Antibody Rituximab.ACS omega · 2025Article
- Establishing Multi-Dimensional LC-MS Systems for Versatile Workflows to Analyze Therapeutic Antibodies at Different Molecular Levels in Routine Operations.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Structure and sequence engineering approaches to improve in vivo expression of nucleic acid-delivered antibodies.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Enhancing therapeutic antibody profiling: orthogonal strategies for stability and quality assessment.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successful application of therapeutic mAbs is based on their ability to precisely interact with their appropriate target sites. The precision of mAbs rely on the isolation techniques delivering pure, consistent, stable, and safe lots that can be used for analytical, diagnostic, or therapeutic applications. During the creation of a biologic, the key quality features of a particular mAb, such as structure, post-translational modifications, and activities at the biomolecular and cellular levels, must be characterized and profiled in great detail. This implies the requirement of powerful state of the art analytical techniques for quality control and characterization of mAbs. Until now, various analytical techniques have been developed to characterize and quantify the mAbs according to the regulatory guidelines. The present review summarizes the major techniques used for the analyses of mAbs which include chromatographic, electrophoretic, spectroscopic, and electrochemical methods in addition to the modifications in these methods for improving the quality of mAbs. This compilation of major analytical techniques will help students and researchers to have an overview of the methodologies employed by the biopharmaceutical industry for structural characterization of mAbs for eventual release of therapeutics in the drug market.
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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.