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2019 White Paper on recent issues in bioanalysis: Part 3 – FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation


The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1–5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity and gene therapy. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS, LBA cell-based/flow cytometry assays and qPCR approaches. This 2019 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance.

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Due to its length, the 2019 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation, Part 3) covers new insights in biomarker assay validation, current and effective strategies for critical reagent management, flow cytometry validation in drug discovery & development & CLSI H62, interpretation of the 2019 FDA immunogenicity guidance and gene therapy bioanalytical challenges.

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