ArticleThe AAPS journal2016
Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics.
Article in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
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
29 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.
- Allelic variation in HLA-DRB1 is associated with development of antidrug antibodies in cancer patients treated with atezolizumab that are neutralizing in vitro.Clinical and translational science · 2022Pooled it
- Development and Validation of Cell-Based Bioassay for the Detection of Neutralizing Antibodies to Ocrelizumab in Human Serum Using Antibody-Dependent Cell-Mediated Cytotoxicity Test in a Reporter Cell Line Expressing FcγRIIIa.Antibodies (Basel, Switzerland) · 2026Article
- Implementing Synthetic Multi-Transmembrane Receptor Protein in a Duplex Immunoassay for Assessment of Neutralizing Antibody to a Bispecific Biotherapeutic.The AAPS journal · 2025Article
- Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules.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
- Current status of the immunogenicity of enzyme replacement therapy in fabry disease.Orphanet journal of rare diseases · 2025Review
- Article
- A Competitive Ligand-Binding Assay for Simultaneous Detection of Neutralizing Antibodies to Both Arms of a Bispecific Drug.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- Immunogenicity assessment strategy for a chemically modified therapeutic protein in clinical development.Frontiers in immunology · 2024Article
- Dynamics and implications of anti-drug antibodies against adalimumab using ultra-sensitive and highly drug-tolerant assays.Frontiers in immunology · 2024Article
- Unique challenges required reassessment and alterations to critical reagents to rescue a neutralizing antibody assay.Bioanalysis · 2024Article
- An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody.The AAPS journal · 2023Article
- Addressing Domain Specificity in the Development of a Cell-Based Binding Assay for the Detection of Neutralizing Antibodies Against a CD47xPD-L1 Bispecific Antibody.The AAPS journal · 2023Article
- Development of a Cell-based Neutralizing Antibody Assay for Zinpentraxin Alfa: Challenges and Mitigation Strategies.The AAPS journal · 2023Article
- Neutralizing Antibody Validation Testing and Reporting Harmonization.The AAPS journal · 2023Article
- Integrated summary of immunogenicity of polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.Frontiers in immunology · 2023Article
- Immunogenicity assessment of AAV-based gene therapies: An IQ consortium industry white paper.Molecular therapy. Methods & clinical development · 2022Review
- When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.The AAPS journal · 2022Article
- Immunogenicity assessment of bispecific antibody-based immunotherapy in oncology.Journal for immunotherapy of cancer · 2022Review
Corrections and comments
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Authors and funding
9 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Most biotherapeutics can elicit immune responses in dosed recipients generating anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) are a subpopulation of ADAs that can potentially impact patient safety and directly mediate loss of drug efficacy by blocking the biological activity of a therapeutic product. Therefore, NAb detection is an important aspect of immunogenicity assessment, requiring sensitive and reliable methods reflective of the therapeutic mechanism of action (MoA). Both cell-based and non cell-based assays are viable options for NAb assessment. However, the scientific approach for the selection of a suitable assay format (cell-based or non cell-based) for NAb assessment is not currently well defined. In this manuscript, the authors summarize the design and utility of cell-based and non cell-based NAb assays and recommend a NAb assay format selection approach that relies on a combination of three factors. These include (i) the therapeutic MoA, (ii) the evidence of desirable assay performance characteristics, and (iii) risk of immunogenicity. The utility of correlating NAb response with pharmacodynamic data is also discussed. The aim of this paper is to provide a consistent strategy that will guide the selection of scientifically justified assay formats capable of detecting clinically relevant NAbs for biotherapeutics with varying MoAs and diverse complexity.
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What OpenQuestion 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 OpenQuestion graph.