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)

• DOI: 10.4155/bio-2024-0024
• Publication Date: 2024-02-23T07:23:42Z
• Authors: Johanna Mora; Rachel Palmer; Leslie Wagner; Bonnie Wu; Michael Partridge; Meena; Ivo Sonderegger; John Smeraglia; Nicoletta Bivi; Naveen Dakappagari; Sandra Diebold; Fabio Garofolo; Christine Grimaldi; Warren Kalina; John Kamerud; Sumit Kar; Jean-Claude Marshall; Christian Mayer; Andrew Melton; Keith Merdek; Katrina Nolan; Serge Picard; Weiping Shao; Jessica Seitzer; Yoichi Tanaka; Omar Tounekti; Adam Vigil; Karl Walravens; Joshua Xu; Weifeng Xu; Yuanxin Xu; Lin Yang; Liang Zhu; Daniela Verthelyi; Robert J. Kubiak; Kelly Coble; Swati Gupta; Mohsen Rajabi Abhari; Susan Richards; Yuan Song; Martin Ullmann; Boris Calderon; Isabelle Cludts; George R Gunn; Shalini Gupta; Akiko Ishii-Watabe; Mohanraj Manangee...; Kimberly Maxfield; Fred McCush; Christine O’Day; Kate Peng; Johann Poetzl; Michele Rasamoeli...; Ola M. Saad; Kara Scheibner; Sophie Shubow; Sam Song; Seth Thacker
• Keywords: Excellence; Bioanalysis; White paper; Regulatory Science

The 17th Workshop on Recent Issues in Bioanalysis (17th WRIB) took place Orlando, FL, USA 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 bioanalysis. WRIB included 3 Main Workshops 7 Specialized that together spanned 1 week allow an exhaustive thorough coverage all major issues bioanalysis biomarkers, immunogenicity, gene therapy, cell therapy vaccines. Moreover, in-depth workshops "EU IVDR 2017/746 Implementation impact for Global Biomarker Community: How Comply with these NEW Regulations" "US FDA/OSIS Remote Regulatory Assessments (RRAs)" were special features edition. As previous years, continued gather a wide diversity international, industry opinion leaders authority experts working both small large molecules as well gene, therapies vaccines facilitate sharing discussions focused improving quality, increasing compliance, achieving scientific excellence bioanalytical issues. This 2023 White Paper encompasses recommendations emerging from extensive held during workshop is aimed provide community key information practical solutions addressed, effort enable advances excellence, improved quality better compliance. Due its length, edition this comprehensive has been divided into three parts editorial reasons. publication (Part 3) covers Gene Therapy, Cell Vaccines Biotherapeutics Immunogenicity. Part 1A (Mass Spectrometry Assays Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) 2 (Biomarkers, IVD/CDx, LBA Cell-Based Assays) are published volume 16 Bioanalysis, 8 9 (2024), respectively.