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2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 3 – Lba, Biomarkers and Immunogenicity)

2015; Future Science Ltd; Volume: 7; Issue: 24 Linguagem: Inglês

10.4155/bio.15.226

1757-6199

Lakshmi Amaravadi, An Song, Heather Myler, Theingi M. Thway, Susan Kirshner, Viswanath Devanarayan, Yan G. Ni, Fabio Garofolo, Herbert Birnboeck, Susan Richards, Shalini Gupta, Linlin Luo, Clare Kingsley, Laura I. Salazar‐Fontana, Stephanie Fraser, Boris Gorovits, John Allinson, Troy E. Barger, Shannon Chilewski, Marianne Scheel Fjording, Sam Haidar, M. Rafiqul Islam, Birgit Jaitner, John Kamerud, Noriko Katori, Corinna Krinos‐Fiorotti, David Lanham, Mark Ma, Jim McNally, Alyssa Morimoto, Daniel T. Mytych, André Nogueira da Costa, Apollon Papadimitriou, Renuka Pillutla, Soma Ray, Afshin Safavi, Natasha Savoie, Martin Schaefer, Judy Shih, John Smeraglia, Michael Skelly, Jeffrey Spond, Roland F. Staack, Bruce Stouffer, Nilufer Tampal, Albert Torri, Jan Welink, Tong‐Yuan Yang, Jad Zoghbi,

Monoclonal and Polyclonal Antibodies Research

The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5 day, week-long event – A Full Immersion Bioanalytical Week – specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS and LBA approaches, including the focus on biomarkers and immunogenicity. This 2015 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 2015 edition of this comprehensive White Paper has been divided into three parts. Part 3 discusses the recommendations for large molecule bioanalysis using LBA, biomarkers and immunogenicity. Part 1 (small molecule bioanalysis using LCMS) and Part 2 (hybrid LBA/LCMS and regulatory inputs from major global health authorities) have been published in volume 7, issues 22 and 23 of Bioanalysis, respectively.