DOI: 10.4155/bio-2023-0151 ISSN:

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Ve

Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Mitra Azadeh, Abbas Bandukwala, Liching Cao, Xiulian Du, Gabriela Franco Salinas, Fabio Garofolo, Shannon Harris, Shirley Hopper, Chad Irwin, Qin Ji, Julie Joseph, Lindsay King, Arvind Kinhikar, Yang Lu, Rosa Luo, Omar Mabrouk, Ludovic Malvaux, Jean-Claude Marshall, Kristina McGuire, Vincent Mikol, Robert Neely, Xiazi Qiu, Yoshiro Saito, Bruno Salaun, Ingrid Scully, John Smeraglia, Therese Solstad, Jeroen Stoop, Huaping Tang, Priscila Teixeira, Yixin Wang, Mike Wright, Luis Mendez, Chris Beaver, Jacqueline Eacret, Amelia Au-Yeung, Vilma Decman, Francis Dessy, Steven Eck, Polina Goihberg, Enrique Gomez Alcaide, Christele Gonneau, Katharine Grugan, Michael Nathan Hedrick, Sumit Kar, Sarita Sehra, Erin Stevens, Chad Stevens, Yongliang Sun, Fred McCush, LaKenya Williams, Sally Fischer, Bonnie Wu, Gregor Jordan, Chris Burns, Isabelle Cludts, Kelly Coble, Christine Grimaldi, Neil Henderson, Alison Joyce, Gregor Lotz, Yanmei Lu, Linlin Luo, Florian Neff, Gizette Sperinde, Kay-Gunnar Stubenrauch, Yuting Wang, Mark Ware, Weifeng Xu
  • Medical Laboratory Technology
  • Clinical Biochemistry
  • General Pharmacology, Toxicology and Pharmaceutics
  • General Medicine
  • Analytical Chemistry

The 16th Workshop on Recent Issues in Bioanalysis (16th WRIB) took place in Atlanta, GA, USA on September 26–30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on ICH M10 BMV final guideline (focused on this guideline training, interpretation, adoption and transition); mass spectrometry innovation (focused on novel technologies, novel modalities, and novel challenges); and flow cytometry bioanalysis (rising of the 3rd most common/important technology in bioanalytical labs) were the special features of the 16th edition.

As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2022 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the 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 2022 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on LBA, Biomarkers/CDx and Cytometry. Part 1 (Mass Spectrometry and ICH M10) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 16 and 14 (2023), respectively.

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