2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (<underline>Part 1</underline> - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies world...

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Main Authors:	Alley, S.C (Author), Bateman, K. (Author), Beaver, C.J (Author), Boer, J. (Author), Buonarati, M. (Author), Dandamudi, S. (Author), Dasgupta, A. (Author), Dean, B. (Author), Dillen, L. (Author), Edmison, A. (Author), Elliott, R. (Author), Evans, C. (Author), Fandozzi, C. (Author), Faustino, P. (Author), Ferrari, L. (Author), Fraier, D. (Author), Garofolo, F. (Author), Gorovits, B. (Author), Haidar, S. (Author), Hughes, N. (Author), Ji, A. (Author), Jian, W. (Author), Lee, A. (Author), Li, W. (Author), Lima Santos, G.M (Author), Luo, L. (Author), McGuinness, M. (Author), Mirza, T. (Author), Mylott, B. (Author), Neubert, H. (Author), Nouri, P. (Author), Olah, T. (Author), Post, N. (Author), Qian, M. (Author), Savoie, N. (Author), Shakleya, D. (Author), Spellman, D.S (Author), Sporring, S. (Author), Stojdl, S. (Author), Summerfield, S. (Author), Sundman, P. (Author), Sydor, J. (Author), Tampal, N. (Author), Vinter, S. (Author), Voelker, T. (Author), Wang, J. (Author), Welink, J. (Author), Wilson, A. (Author), Woolf, E. (Author), Wu, J. (Author), Yang, E. (Author), Yu, H. (Author), Zhang, H. (Author), Zhang, J. (Author)
Format:	Article
Language:	English
Published:	Future Medicine Ltd. 2021
Subjects:	analytic method antisense oligonucleotide Article bioanalysis bioassay Biological Assay biological therapy biomarkers biotechnology Cell- and Tissue-Based Therapy cell therapy cytometry data integrity drug determination drug industry exosome flow cytometry gene therapy Genetic Therapy history History, 21st Century human Humans immunogenicity leadership liquid chromatography mass spectrometry Mass Spectrometry microbiological examination procedures protocol compliance publishing quality control reverse transcription polymerase chain reaction sensitivity and specificity small interfering RNA vaccine workshop WRIB
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