| Literature DB >> 33511867 |
Susan Spitz1, Yan Zhang2, Sally Fischer3, Kristina McGuire4, Ulrike Sommer5, Lakshmi Amaravadi6, Abbas Bandukwala7, Steven Eck8, Fabio Garofolo9, Rafiqul Islam10, Gregor Jordan11, Lindsay King12, Yoshiro Saito13, Giane Sumner4, Linda Terry14, Alessandra Vitaliti5, Yow-Ming Wang7, Christine Grimaldi15, Alison Joyce16, Rachel Palmer17, Matthew Andisik4, Marcela Araya18, Mitra Azadeh19, Daniel Baltrukonis20, Rebecca Elliott3, Sam Haidar7, Seema Kumar21, Andrew Mayer22, Florian Neff11, Nisha Palackal4, Kun Peng3, Mohsen Rajabi Abhari7, Christina Satterwhite23, Natasha Savoie24, Catherine Soo25, Stephen Vinter26, Jan Welink27, Weili Yan3, Kevin Maher7, David Lanham28, Sylvie Bertholet29, Naveen Dakappagari30, Christèle Gonneau31, Cherie Green3, Fabian Junker32, Sumit Kar24, Lisa Patti-Diaz33, Shyam Sarikonda30, Megan McCausland34, Priscila Camillo Teixeira32, Vilma Decman35, Jose Estevam19, Michael Hedrick36, Alberto Hidalgo Robert3, Gregory Hopkins37, Sandra Nuti29, Shabnam Tangri30, Richard Wnek38, Suman Dandamudi7, Arindam Dasgupta7, Anna Edmison25, Patrick Faustino7, Michael McGuinness26, Gustavo Mendes Lima Santos39, Tahseen Mirza7, Diaa Shakleya7, Susan Stojdl25, Nilufer Tampal7, Jinhui Zhang7, Elana Cherry25, Isabelle Cludts40, Andrew Exley26, Akiko Ishii-Watabe13, Susan Kirshner7, Joao Pedras-Vasconcelos7, Meiyu Shen7, Richard Siggers25, Therese Solstad41, Daniela Verthelyi7, Haoheng Yan7, Lucia Zhang25.
Abstract
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 covers the recommendations on (Part 2A) BAV, PK LBA, Flow Cytometry Validation and Cytometry Innovation and (Part 2B) Regulatory Input. Part 1 (Innovation in Small Molecules, Hybrid LBA/LCMS & Regulated Bioanalysis), Part 3 (Vaccine, Gene/Cell Therapy, NAb Harmonization and Immunogenicity) are published in volume 13 of Bioanalysis, issues 4, and 6 (2021), respectively.Keywords: WRIB; bioanalysis; biomarkers; cell therapy; gene therapy; immunogenicity; vaccine
Year: 2021 PMID： 33511867 DOI： 10.4155/bio-2021-0005
Source DB: PubMed Journal: Bioanalysis ISSN： 1757-6180 Impact factor: 2.681