White Papers
2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation
December 1, 2019
Immune Monitoring
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2019 White Paper on Recent Issues in Bioanalysis: Chromatographic Assays(Part 1 – Innovation in Small Molecules and Oligonucleotides & Mass Spectrometric Method Development Strategies for Large Molecule Bioanalysis)
January 1, 2019
Proteomics/Mass Spectrometry
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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback(Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)
December 18, 2018
Immune Monitoring
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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV(Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
December 18, 2018
Immune Monitoring
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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance(Part 3 – LBA: immunogenicity, biomarkers and PK assays)
January 1, 2017
Proteomics/Mass Spectrometry
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