ArticleBioanalysis2024
Re-thinking the current paradigm for clinical immunogenicity assessment: an update from the discussion in the European Bioanalysis Forum.
Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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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.
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Who cites it
19 citing papers in PubMed.
- Minimum Significant Ratio for Defining Treatment-Boosted ADA Responses Using Signal-to-Noise as an Alternative to Titer.The AAPS journal · 2026Article
- Advanced assay design for characterizing anti-drug antibody responses in clinical serum samples.Bioanalysis · 2026Review
- Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.The AAPS journal · 2026Review
- Rethinking immunogenicity: an integrated approach reveals the PK/PD impact of pre-existing and drug-sustaining ADA.Bioanalysis · 2026Article
- From tiers to truth - a biomarker-based framework for clinically relevant immunogenicity assessment.Bioanalysis · 2026Article
- Assessment of Immune Responses Against AAV Encoded Transgene Products.The AAPS journal · 2026Review
- Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug antibody testing strategy.Frontiers in immunology · 2026Article
- Lipid nanoparticle-based mRNA platforms for mucosal HIV vaccines: formulation advances, immune mechanisms, and translational pathways.Archives of microbiology · 2025Review
- Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live Without.The AAPS journal · 2025Article
- Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays.The AAPS journal · 2025Review
- Impact of drug concentration and ADA assay drug tolerance on the assessment and correlation of titer and signal to noise.Bioanalysis · 2025Article
- Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.Bioanalysis · 2025Article
- Stability of Anti-Drug Antibodies Against Antibody Therapeutics.The AAPS journal · 2025Article
- Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Challenging the Standard Immunogenicity Assessment Approach: 1-Tiered ADA Testing Strategy in Clinical Trials.The AAPS journal · 2024Article
- The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays.Bioanalysis · 2024Article
- A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.Bioanalysis · 2024Article
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Corrections and comments
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunogenicity regulatory guidance and industry recommendations have evolved over the last two decades since unexpected immune reactions were first reported with erythropoietin. Since then, the guidelines and practices for immunogenicity have stemmed from a reaction to a high-risk molecule causing significant clinical impact. Similar thinking is often applied to all biotherapeutic drugs, even when a well-defined risk assessment suggests otherwise. In recent years, the current testing paradigm for immunogenicity has been challenged with more informative approaches being proposed. In a Focus Workshop held by the European Bioanalysis Forum in September 2023, the current immunogenicity testing paradigm was challenged based on the experience and learning of 20+ years of immunogenicity strategies. The workshop recommendations proposed a new paradigm, challenging the value of multiple tiers depending on the immunogenicity risk assessment based on context of use and moving toward treating immunogenicity as a pharmacodynamic biomarker for the drug. Such rethinking ultimately results in the appropriate and efficient focusing of resources on immunogenicity testing strategies that benefit patients most, moving to a new paradigm where implementation of appropriate and truly informative immunogenicity testing strategies, depending on the context-of-use, become the norm .
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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.