2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 – LBA and immunogenicity)

Author:

Stevenson Lauren1,Amaravadi Lakshmi1,Myler Heather2,Salazar-Fontana Laura3,Gorovits Boris4,Kirshner Susan3,Xue Li4,Garofolo Fabio5,Alley Stephen C6,Thway Theingi7,Joyce Alison4,Bansal Surendra8,Beaver Chris9,Bergeron Annik5,Cai Xiao-Yan10,Cojocaru Laura11,DeSilva Binodh2,Dumont Isabelle5,Fluhler Eric12,Fraser Stephanie13,Gouty Dominique14,Gupta Swati15,Haidar Sam3,Hayes Roger16,Ingelse Benno17,Ishii-Watabe Akiko18,Kaur Surinder19,King Lindsay13,Laterza Omar20,Leung Sheldon4,Lévesque Ann21,Ma Mark7,Petit-Frere Corinne22,Pillutla Renuka2,Rose Mark7,Schultz Gary23,Smeraglia John24,Swanson Steven7,Torri Albert25,Vazvaei Faye8,Wakelin-Smith Jason26,Wilson Amanda27,Woolf Eric28,Yang Tong-Yuan29

Affiliation:

1. Biogen Idec Inc., Cambridge, MA, USA

2. Bristol-Myers Squibb, Princeton, NJ, USA

3. US FDA, Silver Spring, MD, USA

4. Pfizer, Andover, MA, USA

5. Algorithme Pharma, Inc., 575 Armand-Frappier Blvd., Laval (Montreal), QC H7V 4B3, Canada

6. Seattle Genetics Inc., Bothell, WA, USA

7. Amgen Inc., Thousand Oaks, CA, USA

8. Roche Innovation Center, New York, NY, USA

9. inVentiv Health Clinical, Montreal, QC, Canada

10. Merck, Kenilworth, NJ, USA

11. Tandem Labs, West Trenton, NJ, USA

12. Pfizer, Pearl River, NY, USA

13. Pfizer, Groton, CT, USA

14. Intertek, San Diego, CA, USA – Presently working at BioAgilytix Labs

15. Allergan Inc., Irvine, CA, USA

16. MPI Research, Mattawan, MI, USA

17. Merck, Oss, The Netherlands – Presently working at Quintiles

18. Japan MHLW-NIHS, Tokyo, Japan

19. Genentech, South San Francisco, CA, USA

20. Merck, Whitehouse Station, NJ, USA

21. inVentiv Health Clinical, Quebec City, QC, Canada

22. Roche Innovation Center, Basel, Switzerland

23. Quintiles, Ithaca, NY, USA

24. UCB Pharma, Braine-l’Alleud, Belgium

25. Regeneron Pharmaceuticals, Tarrytown, NY, USA

26. UK MHRA, London, UK

27. AstraZeneca, Macclesfield, UK

28. Merck Research Laboratories, West Point, PA, USA

29. Janssen Research & Development, Spring House, PA, USA

Abstract

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Cited by 39 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

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