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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (part 3-Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization)

Lina Loo,Shannon Harris,Mark Milton, Meena,Wibke Lembke,Flora Berisha,Sylvie Bertholet,Francis Dessy,Robert Dodge,Xiaodong Fang,Michele Fiscella,Fabio Garofolo,Boris Gorovits,Soumi Gupta,Vibha Jawa,Akiko Ishii-Watabe,Brian Long,Yanmei Lu,Timothy Mack,Kristina McGuire,Katrina Nolan,Luying Pan,Bernd Potthoff,Shobha Purushothama,Dean Smith,Therese Solstad,Ivo Sonderegger, Frank Taddeo,Shabnam Tangri,Leslie Wagner,Bonnie Wu,Yuanxin Xu,Susan Kirshner,Daniela Verthelyi,Haoheng Yan,Kimberly Maxfield,Joao Pedras-Vasconcelos,Mohsen Rajabi Abhari,Swati Gupta,Yuling Wu,Manoj Rajadhyaksha,Matthew Andisik,Daniel Baltrukonis,Elana Cherry,Isabelle Cludts,George Gunn,Anders Holm Millner,Gregor Jordan,Sumit Kar,Robert Kubiak,Gregor P. Lotz,Rachel Palmer,Kun Peng,Johann Poetzl,Susan Richards,Natasha Savoie,Roland F. Staack,Kay Stubenrauch,Meenu Wadhwa, Guenter Waxenecker,Tong-Yuan Yang,Lucia Zhang

Bioanalysis（2022）

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