2023 White Paper on recent issues in bioanalysis
Summary
2023 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 (Part 3 – recommendations on gene therapy, cell therapy, vaccines immunogenicity & technologies; biotherapeutics immunogenicity & risk assessment; ADA/NAb assay/reporting harmonization)
The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place in Orlando, FL, USA on June 19–23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.