Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars

Author:

Nicholson Robert1,Lowes Steve2,Caturla Maria Cruz3,Safavi Afshin4,Mamelak Dan5,Islam Rafiq6,Allinson John7,Gouty Dominique8,Khan Masood9,LeLacheur Richard10,Shoup Ronald11,Martinez Suzanne12,Dumont Isabelle12,Zimmer Jennifer13,Steffen Ray14,Petrilla James4,Awaiye Kayode15,Sheldon Curtis16,Turk Douglas17,Fast Douglas18,Kamerud John19,Dinan Andrew20,Lin Zhongping (John)21,Garofolo Wei22,Tang Daniel23,Wright Laura8,Lin Jenny24,Yamashita Yasuhiro24,Liu Yansheng9,Xu Allan25,Hayes Roger26,Bouhajib Mohammed27,Levesque Ann28,Gagnon-Carignan Sofi28,Harman Jake1,Warren Mark29,Karnik Shane30,Cojocaru Laura31,Reuschel Scott32,Gonzalez Pilar33,Fatmi Saadya34,Vija Jenifer35,Rock Marie35,Malone Michele36,Nowatzke William36,Fang Xinping37

Affiliation:

1. PPD, Richmond, VA, USA

2. Advion Bioanalytical Labs, a Quintiles company, Ithaca, NY, USA

3. Anapharm Europe, Barcelona, Spain

4. BioAgilytix Labs, Durham, NC, USA

5. Custom Biologics, Toronto, Ontario, Canada

6. EMD Millipore, St. Charles, MO, USA (presently at Celerion, Lincoln, NE, USA)

7. ICON Development Solutions, Manchester, UK

8. Intertek, San Diego, CA, USA

9. KCAS, Shawnee, KS, USA

10. Agilux Laboratories, Worcester, MA, USA

11. AIT Bioscience, Indianapolis, IN, USA

12. Algorithme Pharma, Laval, Quebec, Canada

13. Alturas Analytics, Moscow, ID, USA

14. BASi, West Lafayette, IN, USA

15. BioPharma Services, Toronto, Ontario, Canada

16. Celerion, Lincoln, NE, USA

17. Cetero Research, Toronto, Ontario, Canada (currently called PRACS Institute, Toronto, Ontario, Canada)

18. Covance Laboratories, Madison, WI, USA

19. Covance Laboratories, Chantilly, VA, USA

20. CPR Pharma Services, Thebarton, South Australia, Australia

21. Frontage Laboratories, Malvern, PA, USA

22. Global CRO Council for Bioanalysis (GCC), 15 Sunview Dr., Toronto, Ontario, L4H 1Y3, Canada.

23. ICON APAC, Shanghai, China

24. JCL Bioassay USA, Hoffman Estates, IL, USA

25. Keystone Bioanalytical, North Wales, PA, USA

26. MPI Research, Mattawan, MI, USA

27. Pharma Medica Research, Toronto, Ontario, Canada

28. PharmaNet Canada, Quebec City, Quebec, Canada

29. PRA International, Lenexa, KS, USA

30. Pyxant Labs, Colorado Springs, CO, USA

31. Tandem Labs, West Trenton, NJ, USA

32. Tandem Labs, Salt Lake City, UT, USA

33. Unilabs York Bioanalytical Solutions, York, UK

34. Warnex Bioanalytical, Laval, Quebec, Canada

35. WIL Research Laboratories, Skokie, IL, USA

36. Worldwide Clinical Trials, Austin, TX, USA

37. XenoBiotic Laboratories, Plainsboro, NJ, USA

Abstract

The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis. The attendance consisted of 45 bioanalytical CRO senior-level representatives on behalf of 37 CRO companies/sites from six countries. In addition to following up on the issue of co-administered drugs stability and on recommendations regarding the European Medicines Agency guideline, this GCC Closed Forum discussed topics of current interest in the bioanalytical field with focus on ligand-binding assays, such as lot changes for critical reagents, positive controls and reference standards, specificity for endogenous compounds, qualification and validation of biomarker assays, approach for biosimilars and criteria for LC–MS assays of small versus large molecules.

Publisher

Future Science Ltd

Subject

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

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