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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A-Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B-Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Susan Spitz,Yan Zhang, Sally Fischer,Kristina McGuire,Ulrike Sommer,Lakshmi Amaravadi,Abbas Bandukwala,Steven Eck,Fabio Garofolo,Rafiqul Islam,Gregor Jordan,Lindsay King,Yoshiro Saito,Giane Sumner,Linda Terry,Alessandra Vitaliti,Yow-Ming Wang,Christine Grimaldi,Alison Joyce,Rachel Palmer,Matthew Andisik, Marcela Araya,Mitra Azadeh,Daniel Baltrukonis,Rebecca Elliott,Sam Haidar,Seema Kumar,Andrew Mayer,Florian Neff,Nisha Palackal,Kun Peng,Mohsen Rajabi Abhari,Christina Satterwhite,Natasha Savoie,Catherine Soo,Stephen Vinter,Jan Welink,Weili Yan,Kevin Maher,David Lanham,Sylvie Bertholet,Naveen Dakappagari,Christele Gonneau,Cherie Green,Fabian Junker,Sumit Kar,Lisa Patti-Diaz,Shyam Sarikonda,Megan McCausland,Priscila Camillo Teixeira,Vilma Decman,Jose Estevam,Michael Hedrick,Alberto Hidalgo Robert,Gregory Hopkins,Sandra Nuti,Shabnam Tangri,Richard Wnek,Suman Dandamudi,Arindam Dasgupta,Anna Edmison,Patrick Faustino, Michael McGuinness,Gustavo Mendes Lima Santos,Tahseen Mirza,Diaa Shakleya,Susan Stojdl,Nilufer Tampal,Jinhui Zhang,Elana Cherry,Isabelle Cludts,Andrew Exley,Akiko Ishii-Watabe,Susan Kirshner,Joao Pedras-Vasconcelos,Meiyu Shen, Richard Siggers,Therese Solstad,Daniela Verthelyi,Haoheng Yan,Lucia Zhang

BIOANALYSIS（2021）

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