2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)

Authors: Neubert H, Olah T, Lee A, Fraser S, Dodge R, Laterza O, Szapacs M, Alley SC, Saad OM, Amur S, Chen L, Cherry E, Cho SJ, Cludts I, Donato LD, Edmison A, Ferrari L, Garofolo F, Haidar S, Hopper S, Hottenstein S, Ishii-Watabe A, Kassim S, Kurki P, Miscoria G, Palandra J, Pedras-Vasconcelos J, Piccoli S, Rogstad S, Saito Y, Santos GML, Savoie N, Sikorski T, Spitz S, Staelens L, Verthelyi D, Vinter S, Wadhwa M, Wang YM, Welink J, Weng N, Whale E, Woolf E, Wu J, Yan H, Yuan H, Zhou S
Publication: Bioanalysis
Division: Regulatory Strategies

Abstract

The 2018 12th Workshop on Recent Issues in Bioanalysis took place in Philadelphia, PA, USA on April 9-13, 2018 with an attendance of over 900 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers and immunogenicity. As usual, it was specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest including both small- and large-molecule bioanalysis involving LCMS, hybrid LBA/LCMS and LBA/cell-based assays approaches. This 2018 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 2018 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for PK, PD and ADA assays by hybrid LBA/LCMS and regulatory agencies’ input. Part 1 (LCMS for small molecules, peptides, oligonucleotides and small molecule biomarkers) and Part 3 (LBA/cell-based assays: immunogenicity, biomarkers and PK assays) are published in volume 10 of Bioanalysis, issues 22 and 24 (2018), respectively.

By Hendrik Neubert, Timothy Olah, Anita Lee, Stephanie Fraser, Robert Dodge, Omar Laterza, Matthew Szapacs, Stephen C Alley, Ola M Saad, Shashi Amur, Linzhi Chen, Elana Cherry, Seongeun Julia Cho, Isabelle Cludts, Lorella Di Donato, Anna Edmison, Luca Ferrari, Fabio Garofolo, Sam Haidar, Shirley Hopper, Scott Hottenstein, Akiko Ishii-Watabe, Sean Kassim, Pekka Kurki, Gustavo Mendes Lima Santos, Gilles Miscoria, Joe Palandra, João Pedras-Vasconcelos, Steven Piccoli, Sarah Rogstad, Yoshiro Saito, Natasha Savoie, Timothy Sikorski, Susan Spitz, Ludovicus Staelens, Daniela Verthelyi, Stephen Vinter, Meenu Wadhwa, Yow-Ming Wang, Jan Welink, Naidong Weng, Emma Whale, Eric Woolf, Jiang Wu, Haoheng Yan, Hongbin Yu, & Shaolian Zhou