DOI: 10.4155/bio-2023-0167 ISSN:

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, C

Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Surinder Kaur, John Kellie, Wenkui Li, John Mehl, Mark Qian, Xiazi Qiu, Federico Riccardi Sirtori, Anton I. Rosenbaum, Tim Sikorski, Sekhar Surapaneni, Jian Wang, Amanda Wilson, Jinhui Zhang, Yongjun Xue, Noah Post, Yue Huang, Dina Goykhman, Long Yuan, Kasie Fang, Ellen Casavant, Linzhi Chen, Yunlin Fu, Ming Huang, Allena Ji, Jay Johnson, Michael Lassman, Jing Li, Ola Saad, Hetal Sarvaiya, Lin Tao, Yuting Wang, Naiyu Zheng, Arindam Dasgupta, Mohsen Rajabi Abhari, Akiko Ishii-Watabe, Yoshiro Saito, Dulcyane Neiva Mendes Fernandes, Joseph Bower, Chris Burns, Kevin Carleton, Seongeun (Julia) Cho, Xiulian Du, Marianne Fjording, Fabio Garofolo, Sumit Kar, Olga Kavetska, Elham Kossary, Yang Lu, Andrew Mayer, Nisha Palackal, Danielle Salha, Eric Thomas, Tom Verhaeghe, Stephen Vinter, Katty Wan, Yow-Ming Wang, Kathi Williams, Eric Woolf, Li Yang, Eric Yang, Abbas Bandukwala, Shirley Hopper, Kevin Maher, Joshua Xu, Eric Brodsky, Isabelle Cludts, Chad Irwin, Julie Joseph, Susan Kirshner, Mohanraj Manangeeswaran, Kimberly Maxfield, Joao Pedras-Vasconcelos, Therese Solstad, Seth Thacker, Omar Tounekti, Daniela Verthelyi, Meenu Wadhwa, Leslie Wagner, Takenori Yamamoto, Lucia Zhang, Lin Zhou
  • 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 the 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 1A) covers the recommendations on Mass Spectrometry and ICH M10. Part 1B covers the Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine. Part 2 (LBA, Biomarkers/CDx and Cytometry) and Part 3 (Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity) are published in volume 15 of Bioanalysis, issues 15 and 14 (2023), respectively.

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