Open Access2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)
Author(s) -
Lauren Stevenson,
Lakshmi Amaravadi,
Heather Myler,
Laura I. SalazarFontana,
Boris Gorovits,
Susan Kirshner,
Xue Li,
Fabio Garofolo,
Stephen C. Alley,
Theingi M. Thway,
Alison Joyce,
Surendra K. Bansal,
Chris Beaver,
Annik Bergeron,
Xiaoyan Cai,
Laura Cojocaru,
Binodh DeSilva,
Isabelle Dumont,
Eric Fluhler,
Stephanie Fraser,
Dominique Gouty,
Swati Gupta,
Sam Haidar,
Roger N. Hayes,
Benno Ingelse,
Akiko IshiiWatabe,
Surinder Kaur,
Lindsay King,
Omar Laterza,
Sheldon S. Leung,
Ann Lévesque,
Mark Ma,
Corinne Petit-Frère,
Renuka Pillutla,
Mark J. Rose,
Gary Schultz,
John Smeraglia,
Steven J. Swanson,
Albert Torri,
Faye Vazvaei,
Jason Wakelin-Smith,
Amanda Wilson,
Eric Woolf,
TongYuan Yang
Publication year - 2014
Publication title -
bioanalysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.566
H-Index - 58
eISSN - 1757-6199
pISSN - 1757-6180
DOI - 10.4155/bio.14.283
Subject(s) - bioanalysis , immunogenicity , biopharmaceutical , nanotechnology , white paper , computer science , engineering ethics , political science , engineering , medicine , materials science , microbiology and biotechnology , biology , immune system , law , immunology
The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years’ editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for Large molecules bioanalysis using LBA and Immunogenicity. Part 1 (Small molecules bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input) were published in the Bioanalysis issues 6(22) and 6(23), respectively.