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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3-Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

Bart Corsaro,Tong-yuan Yang,Rocio Murphy,Ivo Sonderegger,Andrew Exley,Sylvie Bertholet,Naveen Dakappagari,Francis Dessy,Fabio Garofolo,Lisa Kierstead, Holger Koch,Ghanashyam Sarikonda,Natasha Savoie, Richard Siggers,Therese Solstad,Yanmei Lu,Mark Milton,Jean-Claude Marshall,Jason DelCarpini,Boris Gorovits,Swati Gupta,Lynne Jesaitis,John Kamerud,Arno Kromminga, Anna Ma,Jim McNally,Haoheng Yan,Bonnie Wu,Daniela Verthelyi,Susan Kirshner,Joao Pedras-Vasconcelos,Manoj Rajadhyaksha,Roland F. Staack,Elana Cherry,Isabelle Cludts,Madeleine Dahlback,George R. Gunn,Akiko Ishii-Watabe,Vibha Jawa,Robert Kubiak,Michael Partridge,Marco Petrillo,Samuel O. Pine,Johann Poetzl, Sam Song, Chris Stebbins,Yuling Wu,Lucia Zhang,Sumit Kar,Meina Liang,Mohsen Rajabi Abhari,Becky Schweighardt,Kay Stubenrauch,Yuanxin Xu

BIOANALYSIS（2021）

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Key words
bioanalysis,biomarkers,cell therapy,gene therapy,immunogenicity,vaccine,WRIB
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