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)

Author:

Gupta Shalini1,Richards Susan2,Amaravadi Lakshmi2,Piccoli Steven3,Desilva Binodh4,Pillutla Renuka4,Stevenson Lauren5,Mehta Devangi5,Carrasco-Triguero Montserrat6,Neely Robert4,Partridge Michael7,Staack Roland F8,Zhao Xuemei9,Gorovits Boris10,Kolaitis Gerry4,Sumner Giane7,Stubenrauch Kay-Gunnar8,Zou Linglong11,Amur Shashi12,Beaver Chris13,Berger Isabella14,Berisha Flora15,Birnboeck Herbert16,Bower Joe17,Cho Seongeun (Julia)12,Cludts Isabelle18,Cocea Laurent19,Donato Lorella Di20,Fischer Saloumeh6,Fraser Stephanie21,Garofolo Fabio22,Haidar Sam12,Haulenbeek Jonathan4,Hottenstein Charles23,Hu Jenny1,Ishii-Watabe Akiko24,Islam Rafiq25,Jani Darshana10,Kadavil John12,Kamerud John26,Kramer Daniel27,Kurki Pekka28,MacMannis Stephen21,McNally Jim29,Mullan Ashley30,Papadimitriou Apollon8,Pedras-Vasconcelos João12,Ray Soma31,Safavi Afshin32,Saito Yoshiro24,Savoie Natasha33,Fjording Marianne Scheel34,Scheibner Kara12,Smeraglia John35,Song An6,Stouffer Bruce36,Tampal Nilufer12,der Strate Barry van37,Verch Thorsten38,Welink Jan39,Xu Yuanxin40,Yang Tong-yuan41,Yengi Lilian42,Zeng Jianing4,Zhang Yan4,Zhang Yanhua21,Zoog Stephen43

Affiliation:

1. Amgen, Thousand Oaks, CA, USA

2. Sanofi, Framingham, MA, USA

3. Neoteric, Princeton, NJ, USA

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

5. Biogen, Cambridge, MA, USA

6. Genentech, South San Francisco, CA, USA

7. Regeneron Pharmaceuticals, Tarrytown, NY, USA

8. Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany

9. Merck, Rahway, NJ, USA

10. Pfizer, Andover, MA, USA

11. Teva Pharmaceuticals, West Chester, PA, USA

12. US FDA, Silver Spring, MD, USA

13. InVentiv Health, Montreal, QC, Canada

14. Austria AGES, Wien, Austria

15. Daiichi Sankyo, Edison, NJ, USA

16. Roche Pharma Research & Early Development, Roche Innovation Center, Basel, Switzerland

17. Covance, Chantilly, VA, USA

18. UK MHRA-NIBSC, London, UK

19. Health Canada, Ottawa, ON, Canada

20. Caprion Biosciences, Montreal, QC, Canada

21. Pfizer, Groton, CT, USA

22. Angelini Pharma, Pomezia, RM, Italy

23. GlaxoSmithKline, King of Prussia, PA, USA

24. Japan MHLW-NIHS, Tokyo, Japan

25. Celerion, Lincoln, NE, USA

26. Eurofins Bioanalytical Services, St Charles, MO, USA

27. Sanofi, Frankfurt am Main, Germany

28. Finland Fimea, Helsinki, Finland

29. EMD Serono, Billerica, MA, USA

30. MedImmune, Mount Airy, MD, USA

31. Vertex Pharmaceuticals, Boston, MA, USA

32. Bioagilytix Labs, Durham, NC, USA

33. CFABS, Laval, QC, Canada

34. Novo Nordisk, Maaloev, Denmark

35. UCB Biopharma, Braine L'Alleud, Belgium

36. PPD, Richmond, VA, USA

37. PRA Health Sciences, Assen, The Netherlands

38. Merck, West Point, PA, USA

39. Dutch MEB, Utrecht, The Netherlands

40. Alnylam Pharmaceuticals, Cambridge, MA, USA

41. Janssen R&D, Spring House, PA, USA

42. Bluebirdbio, Cambridge, MA, USA

43. BioMarin Pharmaceutical, San Rafael, CA, USA

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.

Publisher

Future Science Ltd

Subject

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

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