2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( <u>Part 1</u> –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)
Hendrik Neubert, Stephen C. Alley, Anita Lee, Wenying Jian, Michael H. Buonarati, Anna Edmison, Fabio Garofolo, Boris Gorovits, Sam Haidar, Bill Mylott, Parya Nouri, Mark G. Qian, Stephen Vinter, Troy Voelker, Jan Welink, Jiang Wu, Eric Yang, Hongbin Yu, Chris Evans, Scott Summerfield, Jian Wang, Kevin P. Bateman, Jason Boer, Brian Dean, Lieve Dillen, Patrick J. Faustino, Luca Ferrari, Nicola Hughes, Lina Luo, Timothy Olah, Noah Post, Daniel S. Spellman, Jens Sydor, Hui Zhang, Jenny Zhang, Jinhui Zhang, Christine Fandozzi, Amanda Wilson, Daniela Fraier, Christopher Beaver, Suman Dandamudi, Arindam Das-Gupta, Rebecca Elliott, Allena Ji, Wenkui Li, Michael McGuinness, Gustavo Mendes Lima Santos, Tahseen Mirza, Natasha Savoie, Diaá M. Shakleya, Sune Hove Sporring, Susan Stojdl, Phillip Sundman, Nilufer Tampal, Eric Woolf
Abstract
WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by Mass Spectrometry (hybrid assays, LCMS and HRMS) were special features in 2020. As in previous years, this year's WRIB continued to gather a wide diversity of international industry opinion leaders and regulatory authority experts working on both small and large molecules to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance and achieving scientific excellence on bioanalytical issues. This 2020 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the Global Bioanalytical Community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2020 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication covers the recommendations on (Part 1) Hybrid Assays, Innovation in Small Molecules, & Regulated Bioanalysis. Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation), Part 2B (Regulatory Input) and Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 5, and 6 (2021), respectively.