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Bioanalysis. 2016 Nov;8(22):2363-2378. doi: 10.4155/bio-2016-4992. Epub 2016 Oct 7.

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 - small molecules, peptides and small molecule biomarkers by LCMS).

Author information

1
GlaxoSmithKline, King of Prussia, PA, USA.
2
Dutch MEB, Utrecht, The Netherlands.
3
Covance, Madison, WI, USA.
4
Merck Research Labs, West Point, PA, USA.
5
AbbVie Inc., North Chicago, IL, USA.
6
Amgen, Thousand Oaks, CA, USA.
7
Previously at Bristol-Myers Squibb, Princeton, NJ, USA; currently at Bioanalytical Solution Integration LLC, Burlington, NJ, USA.
8
LGC, Cambridge, UK.
9
Austria AGES, Wien, Austria.
10
Intertek, San Diego, CA, USA.
11
Bristol-Myers Squibb, Princeton, NJ, USA.
12
Angelini Pharma, Pomezia, RM, Italy.
13
Bioanalytical Laboratory Services a Division of LifeLabs LP, Toronto, ON, Canada.
14
Celerion, Lincoln, NE, USA.
15
PPD, Middleton, WI, USA.
16
AstraZeneca, Cambridge, UK.
17
PRA Health Sciences, Overland Park, KS, USA.
18
Health Canada, Ottawa, ON, Canada.
19
Apotex, Toronto, ON, Canada.
20
WHO, Geneva, Switzerland.
21
Bristol-Myers Squibb, Wallingford, CT, USA.
22
F. Hoffmann-La Roche, Basel, Switzerland.
23
PPD, Richmond, VA, USA.
24
US FDA, Silver Spring, MD, USA.
25
UCB, Slough, UK.
26
Novartis, East Hanover, NJ, USA.
27
Brazil Anvisa, Brasilia, Brazil.
28
Pharmascience, Montreal, QC, Canada.
29
Pfizer, Groton, CT, USA.
30
Japan MHLW-NIHS, Tokyo, Japan.
31
CFABS, Montreal, QC, Canada.
32
GlaxoSmithKline, Ware, UK.
33
BASi, West Lafayette, IN, USA.
34
UK MHRA, London, UK.
35
Novartis, Emeryville, CA, USA.

Abstract

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including 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 LCMS, hybrid LBA/LCMS, and LBA approaches, with the focus on biomarkers and immunogenicity. This 2016 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. This white paper is published in 3 parts due to length. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LCMS. Part 2 (Hybrid LBA/LCMS and regulatory inputs from major global health authorities) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in the Bioanalysis journal, issue 23.

PMID:
27712081
DOI:
10.4155/bio-2016-4992
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