ReviewJournal of immunology research2016
Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications.
Review in Journal of immunology research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 92 papers, 1 of them a synthesis that pooled it.
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
92 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Low immunogenicity of insulin efsitora alfa in participants with type 1 and type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2026Pooled it
- Trial
- Immune tolerance platforms to mitigate unwanted immune responses.Journal of pharmaceutical sciences · 2026Review
- 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
- Widespread Molecular Imprints in the Serum Proteome of COVID-19 Convalescents Uncovering Immune System Sequelae.Molecular & cellular proteomics : MCP · 2026Article
- Artificial lipidation of proteins and peptides: from mechanism to clinical applications.The FEBS journal · 2026Review
- Clinical MAPPs: a personalized healthcare-driven assay for the direct identification of potential T cell epitopes in patients.Frontiers in immunology · 2026Article
- CRISPR-engineered microbiome: living therapeutics revolutionize blood cancer immunotherapy.NPJ biofilms and microbiomes · 2025Review
- Therapeutic Applications and Mechanisms of Superoxide Dismutase (SOD) in Different Pathogenesis.Biomolecules · 2025Review
- PET Imaging Expedites Detection of Aberration in the Humanization of an Annexin A1 Targeting Antibody.Pharmaceuticals (Basel, Switzerland) · 2025Article
- The Impact of the Lactation Period Gut Microbiota of Two Different Beef Cattle Breeds on Spring-Born Calves.Animals : an open access journal from MDPI · 2025Article
- Article
- Elucidation of B-cell specific drug immunogenicity liabilities via a novelFrontiers in immunology · 2025Article
- Reformation of a Clinical Anti-Drug Antibody Assay to Enable the Immunogenicity Assessment of a Bispecific Antibody Biotherapeutic.The AAPS journal · 2024Article
- Drug Interaction-Informed Approaches to Inflammatory Bowel Disease Management.Pharmaceutics · 2024Review
- Novel and effective screening system for recombinant protein production in CHO cells.Scientific reports · 2024Article
- Single Cell Expression Systems for the Production of Recombinant Proteins for Immunodiagnosis and Immunoprophylaxis of Toxoplasmosis.Microorganisms · 2024Review
- Glycosylation of recombinant adeno-associated virus serotype 6.Molecular therapy. Methods & clinical development · 2024Article
- Building blocks needed for mechanistic modeling of bioprocesses: A critical review based on protein production by CHO cells.Metabolic engineering communications · 2024Review
- Reducing Immunogenicity by Design: Approaches to Minimize Immunogenicity of Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
32 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
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Today, potential immunogenicity can be better evaluated during the drug development process, and we have rational approaches to manage the clinical consequences of immunogenicity. The focus of the scientific community should be on developing sensitive diagnostics that can predict immunogenicity-mediated adverse events in the small fraction of subjects that develop clinically relevant anti-drug antibodies. Here, we discuss the causes of immunogenicity which could be product-related (inherent property of the product or might be picked up during the manufacturing process), patient-related (genetic profile or eating habits), or linked to the route of administration. We describe various posttranslational modifications (PTMs) and how they may influence immunogenicity. Over the last three decades, we have significantly improved our understanding about the types of PTMs of biotherapeutic proteins and their association with immunogenicity. It is also now clear that all PTMs do not lead to clinical immunogenicity. We also discuss the mechanisms of immunogenicity (which include T cell-dependent and T cell-independent responses) and immunological tolerance. We further elaborate on the management of immunogenicity in preclinical and clinical setting and the unique challenges raised by biosimilars, which may have different immunogenic potential from their parent biotherapeutics.
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What Socratic 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 Socratic graph.