ReviewmAbs
Forced degradation of recombinant monoclonal antibodies: A practical guide.
Review in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 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
87 citing papers in PubMed.
- The Production and Purification of Therapeutic Antibodies: A Comprehensive Analysis of Process- and Product-Related Contaminants.Biomolecules · 2026Review
- In-depth Characterization of Photo-Stressed Antibody-Drug Conjugates by Mass Spectrometry.The AAPS journal · 2026Article
- Comprehensive forced degradation study revealing diverse chemical and physical degradation pathways of AAV8.Gene therapy · 2026Article
- Analytical Development and Testing Strategy of Antibody-Drug Conjugates.AAPS PharmSciTech · 2026Review
- Toward site-specific characterization of structural perturbations on glycosylated Fc using NMR at natural abundance.Journal of biomolecular NMR · 2026Article
- Stress-Induced Antibody Aggregates: Insights from Native SEC-MS with Postcolumn Denaturation.Journal of the American Society for Mass Spectrometry · 2026Article
- Mechanisms of therapeutic antibodies immunogenicity: infliximab oligomeric aggregates increase T-cell response and uptake by dendritic cells involving mannose-sensitive receptor CD206.Frontiers in immunology · 2026Article
- pH-dependent DNA degradation pathways for adeno-associated virus gene therapy.Molecular therapy. Methods & clinical development · 2025Article
- Article
- Article
- Multimodal mass spectrometric characterization of structural microheterogeneity in rituximab reference and biosimilars.International journal of biological macromolecules · 2025Article
- Structure-Guided In-Use Stability Assessment of Monoclonal Antibody Tislelizumab.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Assessing the Comparability of Degradation Profiles Between Biosimilar and Originator Anti-VEGF Monoclonal Antibodies Under Thermal Stress.Pharmaceuticals (Basel, Switzerland) · 2025Article
- High-Throughput Monoclonal Antibody Peptide Mapping Using 15-s HPLC Gradients Coupled with Cyclic Ion Mobility-Mass Spectrometry.Analytical chemistry · 2025Article
- A Review on the Stability Challenges of Advanced Biologic Therapeutics.Pharmaceutics · 2025Review
- Impact of Monoclonal Antibody Aggregates on Effector Function Characterization.Antibodies (Basel, Switzerland) · 2025Article
- Preclinical Long-Term Stability and Forced Degradation Assessment of EPICERTIN, a Mucosal Healing Biotherapeutic for Inflammatory Bowel Disease.Pharmaceutics · 2025Article
- Review
- Physicochemical and biological impacts of light stress on adeno-associated virus serotype 6.Molecular therapy. Methods & clinical development · 2024Article
- Comprehensive Analysis of Cetuximab Critical Quality Attributes: Impact of Handling on Antigen-Antibody Binding.Pharmaceutics · 2024Article
27 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Forced degradation studies have become integral to the development of recombinant monoclonal antibody therapeutics by serving a variety of objectives from early stage manufacturability evaluation to supporting comparability assessments both pre- and post- marketing approval. This review summarizes the regulatory guidance scattered throughout different documents to highlight the expectations from various agencies such as the Food and Drug Administration and European Medicines Agency. The various purposes for forced degradation studies, commonly used conditions and the major degradation pathways under each condition are also discussed.
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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.