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 <u>(Part 3</u> – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity &amp; Technologies; Biotherapeutics Immunogenicity &amp; Risk Assessment; ADA/NAb Assay/Reporting Harmonization)

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