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European Journal of Immunology|May 14, 2016
Reduced TCR-dependent activation through citrullination of a T-cell epitope enhances Th17 development by disruption of the STAT3/5 balanceChristopher Tibbitt, Jane Falconer, Jeroen Stoop, et al.
NPJ Vaccines|December 18, 2020
Nonhuman primate to human immunobridging to infer the protective effect of an Ebola virus vaccine candidateRamon Roozendaal, Jenny Hendriks, Thierry van Effelterre, et al.
The New England Journal of Medicine|January 13, 2021
Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 VaccineJerald Sadoff, Mathieu Le Gars, Georgi Shukarev, et al.
Bioanalysis|June 22, 2026
Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and TransferJeroen Stoop, James Huleatt, Luc Gagnon, et al.
Bioanalysis|November 14, 2024
Harmonization of Vaccine Ligand Binding Assays ValidationFrancis Dessy, Ivo Sonderegger, Leslie Wagner, et al.
Bioanalysis|January 25, 2025
2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA (<u>PART 2A</u> - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) <u>PART 2B</u> - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation)Nicoletta Bivi, Danielle Graham, Laura Joglekar, et al.
Bioanalysis|August 16, 2023
2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep CharacterizationGiane Sumner, Steve Keller, James Huleatt, et al.
Bioanalysis|January 29, 2026
2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))Sarah Hersey, Kristina McGuire, Olga Kholmanskikh, et al.
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