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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).

Authors :
Gupta S
Richards S
Amaravadi L
Piccoli S
Desilva B
Pillutla R
Stevenson L
Mehta D
Carrasco-Triguero M
Neely R
Partridge M
Staack RF
Zhao X
Gorovits B
Kolaitis G
Sumner G
Stubenrauch KG
Zou L
Amur S
Beaver C
Berger I
Berisha F
Birnboeck H
Bower J
Cho SJ
Cludts I
Cocea L
Donato LD
Fischer S
Fraser S
Garofolo F
Haidar S
Haulenbeek J
Hottenstein C
Hu J
Ishii-Watabe A
Islam R
Jani D
Kadavil J
Kamerud J
Kramer D
Kurki P
MacMannis S
McNally J
Mullan A
Papadimitriou A
Pedras-Vasconcelos J
Ray S
Safavi A
Saito Y
Savoie N
Fjording MS
Scheibner K
Smeraglia J
Song A
Stouffer B
Tampal N
der Strate BV
Verch T
Welink J
Xu Y
Yang TY
Yengi L
Zeng J
Zhang Y
Zhang Y
Zoog S
Source :
Bioanalysis [Bioanalysis] 2017 Dec; Vol. 9 (24), pp. 1967-1996. Date of Electronic Publication: 2017 Dec 05.
Publication Year :
2017

Abstract

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.

Details

Language :
English
ISSN :
1757-6199
Volume :
9
Issue :
24
Database :
MEDLINE
Journal :
Bioanalysis
Publication Type :
Academic Journal
Accession number :
29205064
Full Text :
https://doi.org/10.4155/bio-2017-4974