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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( Part 3 –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)

2021; Future Science Ltd; Volume: 13; Issue: 6 Linguagem: Inglês

10.4155/bio-2021-0007

1757-6199

Bart Corsaro, Tong‐Yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Sylvie Bertholet, Naveen Dakappagari, Francis Dessy, Fabio Garofolo, Lisa Kierstead, Holger M. Koch, Ghanashyam Sarikonda, Natasha Savoie, Richard Siggers, Therese Solstad, Yanmei Lu, Mark Milton, Jean‐Claude Marshall, Jason DelCarpini, Boris Gorovits, Swati Gupta, Lynne Jesaitis, John Kamerud, Arno Kromminga, Anna Ma, Jim McNally, Haoheng Yan, Bonnie Wu, Daniela Verthelyi, Susan Kirshner, João Pedras-Vasconcelos, Manoj Rajadhyaksha, Roland F. Staack, Elana Cherry, Isabelle Cludts, Madeleine Dahlbäck, George R. Gunn, Akiko Ishii‐Watabe, Vibha Jawa, Robert Kubiak, Michael A. Partridge, Marco Petrillo, Samuel Pine, Johann Poetzl, Sam Song, Chris Stebbins, Yuling Wu, Lucia Zhang, Sumit Kar, Meina Liang, Mohsen Rajabi Abhari, Becky Schweighardt, Kay Stubenrauch, Yuanxin Xu,

Advanced Biosensing Techniques and Applications

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 worldwide. The 14th 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 and vaccine. Moreover, a comprehensive vaccine assays track; an enhanced cytometry track and updated Industry/Regulators consensus on BMV of biotherapeutics by LCMS 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 (Part 3) covers the recommendations on Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity). Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 2A (BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation) and Part 2B (Regulatory Input) are published in volume 13 of Bioanalysis, issues 4 and 5 (2020), respectively.