2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Authors: Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L
Publication: Bioanalysis
Keywords: bioanalysis, biomarkers, cell therapy, gene therapy, immunogenicity, vaccine
Division: Regulatory Strategies

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.

By Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Lakshmi Amaravadi, Abbas Bandukwala, Steven Eck, Fabio Garofolo, Rafiqul Islam, Gregor Jordan, Lindsay King, Yoshiro Saito, Giane Sumner, Linda Terry, Alessandra Vitaliti, Yow-Ming Wang, Christine Grimaldi, Alison Joyce, Rachel Palmer, Matthew Andisik, Marcela Araya, Mitra Azadeh, Daniel Baltrukonis, Rebecca Elliott, Sam Haidar, Seema Kumar, Andrew Mayer, Florian Neff, Nisha Palackal, Kun Peng, Mohsen Rajabi Abhari, Christina Satterwhite, Natasha Savoie, Catherine Soo, Stephen Vinter, Jan Welink, Weili Yan, Kevin Maher, David Lanham, Sylvie Bertholet, Naveen Dakappagari, Christèle Gonneau, Cherie Green, Fabian Junker, Sumit Kar, Lisa Patti-Diaz, Shyam Sarikonda, Megan McCausland, Priscila Camillo Teixeira, Vilma Decman, Jose Estevam, Michael Hedrick, Alberto Hidalgo Robert, Gregory Hopkins, Sandra Nuti, Shabnam Tangri, Richard Wnek, Suman Dandamudi, Arindam Dasgupta, Anna Edmison, Patrick Faustino, Michael McGuinness, Gustavo Mendes Lima Santos, Tahseen Mirza, Diaa Shakleya, Susan Stojdl, Nilufer Tampal, Jinhui Zhang, Elana Cherry , Isabelle Cludts, Andrew Exley, Akiko Ishii-Watabe, Susan Kirshner, Joao Pedras-Vasconcelos, Meiyu Shen, Richard Siggers, Therese Solstad, Daniela Verthelyi, Haoheng Yan, Lucia Zhang