2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( PART 2 – Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies) | Synapse

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12023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)2024 · 22 citations
22025 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))Original Research · 2026 · 4 citations
32023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody <u>(PART 1A</u> – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis <u>PART 1B</u> - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/…2024 · 13 citations
42020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( <u>Part 1</u> –Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)Original Research · 2021 · 35 citations
52017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)Original Research · 2017 · 37 citations

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