2018 White Paper on Recent Issues in Bioanalysis: ‘A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)’ (Part 1 – small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis)

Authors: Welink J, Xu Y, Yang E, Wilson A, Henderson N, Luo L, Fraser S, Kavita U, Musuku A, James C, Fraier D, Zhang Y, Goykhman D, Summerfield S, Woolf E, Verhaeghe T, Hughes N, Behling A, Brown K, Bulychev A, Buonarati M, Cherry E, Cho SJ, Cludts I, Dillen L, Dodge R, Edmison A, Garofolo F, Green R, Haidar S, Hottenstein C, Ishii-Watabe A, Jang HG, Ji A, Jones B, Kassim S, Ma M, Santos GML, Norris DA, Owen T, Piccoli S, Ramanathan R, Röhl I, Rosenbaum AI, Saito Y, Sangster T, Savoie N, Stebbins C, Sydor J, de Merbel Nv, Verthelyi D, Vinter S, Whale E
Publication: Bioanalysis
Division: Simulations Plus

Abstract

The 2018 12th Workshop on Recent Issues in Bioanalysis (12th WRIB) 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 full immersion in 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 LC-MS, hybrid ligand binding assay (LBA)/LC-MS 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 1) covers the recommendations for LC-MS for small molecules, peptides, oligonucleotides and small molecule biomarkers. Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies’ inputs) and Part 3 (large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays) are published in volume 10 of Bioanalysis, issues 23 and 24 (2018), respectively.

By Jan Welink, Yuanxin Xu, Eric Yan, Amanda Wilson, Neil Henderson, Lina Luo, Stephanie Fraser, Uma Kavita, Adrien Musuku, Christopher James, Daniela Fraier, Yan Zhang, Dina Goykhman, Scott Summerfield, Eric Woolf, Tom Verhaeghe, Nicola Hughes, Alexander Behling, Kirk Brown, Alex Bulychev, Michael Buonarati, Elana Cherry, Seongeun Julia Cho, Isabelle Cludts, Lieve Dillen, Robert Dodge, Anna Edmison, Fabio Garofolo, Rachel Green, Sam Haidar, Charles Hottenstein, Akiko Ishii-Watabe, Hyun Gyung Jang, Allena Ji, Barry Jones, Sean Kassim, Mark Ma, Gustavo Mendes Lima Santos 29, Daniel A Norris, Tate Owen, Steven Piccoli, Ragu Ramanathan, Ingo Röhl, Anton I Rosenbaum, Yoshiro Saito, Timothy Sangster, Natasha Savoie, Christopher Stebbins, Jens Sydor, Nico van de Merbel, Daniela Verthelyi, Stephen Vinter, & Emma Whale