Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis

Author:

Bower Joseph1,Zimmer Jennifer2,McCown Stacie3,Tabler Edward4,Karnik Shane5,Kar Sumit6,Xu Allan7,Hays Amanda3,Keyhani Anahita8,Brant Ashley9,Hoffpauir Brian10,Kane Cheikh11,Beaver Chris12,Satterwhite Christina13,Barry Colin14,Desai-Krieger Daksha15,Williams Dave16,Dufield Dawn17,Groeber Elizabeth18,Farley Esme19,Garofolo Fabio20,Renfrew Heidi21,Vance Jennifer22,Lin Jenny23,Dong Kelly24,Sales Kurt25,O'Dell Mark26,Luna Marsha27,Sanghvi Mitesh19,Savoie Natasha6,Bravo Orlando28,Sun Rachel28,Islam Rafiq10,Hayes Roger29,Simchik Sarah29,Cape Stephanie30,Lowes Steve31,Lester Todd16,Garofolo Wei6,Fang Xinping32

Affiliation:

1. Precision for Medicine, Frederick, MD, USA

2. Alturas Analytics, Moscow, ID, USA

3. PRA Health Sciences, Lenexa, KS, USA

4. PPD Laboratories, Richmond, VA, USA

5. Pyxant Labs, Colorado Springs, CO, USA

6. GCC, Toronto, ON, Canada

7. Keystone Bioanalytical, Lansdale, PA, USA

8. Altasciences, Everett, WA, USA

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

10. Smithers, Gaithersburg, MD, USA

11. Nexelis, Seattle, WA, USA

12. Syneos Health, Quebec City, QC, Canada

13. Charles River Laboratories, Reno, NV, USA

14. Alliance Pharma, Malvern, PA, USA

15. Worldwide Clinical Trials, Austin, TX, USA

16. BioAgilytix, Durham, NC, USA

17. Intertek, San Diego, CA, USA

18. Charles River Laboratories, Ashland, OH, USA

19. Pharmaron, Germantown, MD, USA

20. BRI Biopharmaceutical Research, Vancouver, BC, Canada

21. Charles River Laboratories, Shrewsbury, MA, USA

22. AIT Bioscience, Indianapolis, IN, USA

23. CMIC, Hoffman Estates, IL, USA

24. United-Power Pharma, Beijing, China

25. Agilex Biolabs, Adelaide, Australia

26. Covance, Indianapolis, IN, USA

27. KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA

28. Inotiv, West Lafayette, IN, USA

29. ICON Laboratory Services, Whitesboro, NY, USA

30. Covance, Madison, WI, USA

31. Q2 Solutions, Ithaca, NY, USA

32. CRMedicon, Piscataway, NJ, USA

Abstract

The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 2019 and consolidate the feedback of the GCC members. While ICH M10 will cover requirements for reference standards, one of the biggest challenges facing the CRO community is the lack of consistency and completeness of Certificates of Analysis for reference standards used in regulated bioanalysis. Similar challenges exist with critical reagents (e.g., capture and detection antibodies) used for assays supporting biologics. The recommendations provided in this publication are the minimum requirements for the content that GCC members believe should be included in Certificates of Analysis for reference standards obtained from commercial vendors, sponsors and compendial suppliers, for use in regulated bioanalytical studies. In addition, recommendations for internal standards, metabolites and critical reagents are discussed.

Publisher

Future Science Ltd

Subject

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

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