ArticleJournal of immunology research2016
Development of Immunocapture-LC/MS Assay for Simultaneous ADA Isotyping and Semiquantitation.
Article 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 16 papers.
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
16 citing papers in PubMed, 44 citations in OpenAlex.
- A Fit-for-purpose Strategy for Clinical Immunogenicity Assessment of Multivalent Bispecific Antibodies.The AAPS journal · 2025Article
- Antibody-Drug Conjugates in Breast Cancer: Navigating Innovations, Overcoming Resistance, and Shaping Future Therapies.Biomedicines · 2025Review
- End-to-End One-Pot Preclinical Immunoaffinity-Liquid Chromatography-Tandem Mass Spectrometry Workflow for Simultaneous Quantitation of Total and Conjugated Antibody Levels of Antibody-Drug Conjugates with Protease-Cleavable Linkers.Analytical chemistry · 2025Article
- Article
- Simultaneous isotyping and semi-quantitation of anti-drug antibodies to an IgG1 biotherapeutic using hybrid LBA-LC-MS/MS.Bioanalysis · 2025Article
- Review
- A Comprehensive Immunocapture-LC-MS/MS Bioanalytical Approach in Support of a Biotherapeutic Ocular PK Study.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Current Analytical Strategies for Antibody-Drug Conjugates in Biomatrices.Molecules (Basel, Switzerland) · 2022Review
- Approaches for the detection and analysis of antidrug antibodies to biopharmaceuticals: A review.Journal of separation science · 2022Review
- Quantification of anti-SARS-CoV-2 antibodies in human serum with LC-QTOF-MS.Journal of pharmaceutical and biomedical analysis · 2021Article
- Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.The AAPS journal · 2021Review
- Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry.The AAPS journal · 2021Article
- Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics.The AAPS journal · 2020Review
- Design and Evaluation of a Multiplexed Assay to Assess Human Immunogenicity Against Humira®.The AAPS journal · 2020Article
- Immunogenicity of Protein Pharmaceuticals.Journal of pharmaceutical sciences · 2019Review
- Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies.Journal of immunology research · 2016Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Therapeutic proteins and peptides have potential to elicit immune responses resulting in anti-drug antibodies that can pose problems for both patient safety and product efficacy. During drug development immunogenicity is usually examined by risk-based approach along with specific strategies for developing "fit-for-purpose" bioanalytical approaches. Enzyme-linked immunosorbent assays and electrochemiluminescence immunoassays are the most widely used platform for ADA detection due to their high sensitivity and throughput. During the past decade, LC/MS has emerged as a promising technology for quantitation of biotherapeutics and protein biomarkers in biological matrices, mainly owing to its high specificity, selectivity, multiplexing, and wide dynamic range. In fully taking these advantages, we describe here an immunocapture-LC/MS methodology for simultaneous isotyping and semiquantitation of ADA in human plasma. Briefly, ADA and/or drug-ADA complex is captured by biotinylated drug or anti-drug Ab, immobilized on streptavidin magnetic beads, and separated from human plasma by a magnet. ADA is then released from the beads and subjected to trypsin digestion followed by LC/MS detection of specific universal peptides for each ADA isotype. The LC/MS data are analyzed using cut-point and calibration curve. The proof-of-concept of this methodology is demonstrated by detecting preexisting ADA in human plasma.
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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.