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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)

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 Manangeeswaran,Kimberly Maxfield,Fred Mccush, Christine O'Day, Kate Peng,Johann Poetzl,Michele Rasamoelisolo,Ola M. Saad,Kara Scheibner, Sophie Shubow, Sam Song,Seth Thacker

BIOANALYSIS（2024）

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关键词
bioanalysis,biomarkers,cell therapy,gene therapy,immunogenicity,vaccine,WRIB
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