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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)

2017; Future Science Ltd; Volume: 9; Issue: 24 Linguagem: Inglês

10.4155/bio-2017-4974

1757-6199

Shalini Gupta, Susan Richards, Lakshmi Amaravadi, Steven P. Piccoli, Binodh DeSilva, Renuka Pillutla, Lauren Stevenson, Devangi Mehta, Montserrat Carrasco‐Triguero, Robert Neely, Michael A. Partridge, Roland F. Staack, Xuemei Zhao, Boris Gorovits, Gerry Kolaitis, Giane Sumner, Kay‐Gunnar Stubenrauch, Linglong Zou, Shashi Amur, Chris Beaver, Isabella Berger, Flora Berisha, Herbert Birnboeck, Joe Bower, Seongeun Cho, Isabelle Cludts, Laurent Cocea, Lorella Di Donato, Saloumeh K Fischer, Stephanie Fraser, Fabio Garofolo, Sam Haidar, Jonathan Haulenbeek, Charles Hottenstein, Jenny Hu, Akiko Ishii‐Watabe, Rafiq Islam, Darshana Jani, John Kadavil, John Kamerud, Daniel Kramer, Pekka Kurki, Stephen MacMannis, Jim McNally, Ashley Mullan, Apollon Papadimitriou, João Pedras-Vasconcelos, Soma Ray, Afshin Safavi, Yoshiro Saito, Natasha Savoie, Marianne Scheel Fjording, Kara Scheibner, John Smeraglia, An Song, Bruce Stouffer, Nilufer Tampal, Barry van der Strate, Thorsten Verch, Jan Welink, Yuanxin Xu, Tong‐Yuan Yang, Lilian Yengi, Jianing Zeng, Yan Zhang, Zhang Yan-hua, Stephen J. Zoog,

Biosensors and Analytical Detection

The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals 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 analysis involving LC-MS, hybrid ligand-binding assay (LBA)/LC-MS and LBA approaches. This 2017 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 2017 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for large-molecule bioanalysis, biomarkers and immunogenicity using LBA. Part 1 (LC-MS for small molecules, peptides and small molecule biomarkers) and Part 2 (hybrid LBA/LC-MS for biotherapeutics and regulatory agencies' inputs) are published in volume 9 of Bioanalysis, issues 22 and 23 (2017), respectively.