Recommendations on qPCR/ddPCR assay validation by GCC

Author:

Wissel Mark1,Poirier Martin2,Satterwhite Christina3,Lin John4,Islam Rafiq5,Zimmer Jennifer6,Khadang Ardeshir7,Zemo Jennifer8,Lester Todd8,Fjording Marianne8,Hays Amanda8,Hughes Nicola9,Garofolo Fabio10,Guilbaud Rudolf11,Groeber Elizabeth12,Renfrew Heidi13,Colletti Kelly3,Yu Mathilde14,Lin Jenny15,Fang Xinping16,Shah Santosh4,Garofolo Wei17,Kar Sumit17,Hayes Roger18,Pirro John19,Kane Cheikh19,Luna Marsha19,Xu Allan20,Cape Stephanie21,O'Dell Mark22,Wheller Robert23,Ritzen Hanna24,Vance Jennifer25,Farley Esme26,Matys Katie27,Tabler Edward27,Mylott William27,Yuan Moucun27,Karnik Shane28,Voelker Troy29,DuBey Ira5,Williard Clark30,Shi Jing31,Yamashita Jim31

Affiliation:

1. Eurofins Viracor BioPharma, Lenexa,Kansas, USA

2. Altasciences, Everett, Washington, USA

3. Charles River Laboratories, Reno, Nevada, USA

4. Frontage Laboratories, Exton, Pennsylvania, USA

5. Smithers, Gaithersburg, Maryland, USA

6. Alturas Analytics, Moscow, Idaho, USA

7. Axis Clinical, Dilworth, Minnesota, USA

8. BioAgilytix, Durham, North Carolina, USA

9. Biopharmaservices, Toronto, Ontario, Canada

10. BRI - a Frontage Company, Vancouver, British Columbia, Canada

11. CellCarta, Montreal, Quebec, Canada

12. Charles River Laboratories, Ashland, Ohio, USA

13. Charles River Laboratories, Shrewsbury, Massachusetts, USA

14. CIRION, Montreal, Quebec, Canada

15. CMIC, Hoffman Estates, Illinois, USA

16. CR Medicon, Piscataway, New Jersey, USA

17. GCC, Toronto, Ontario, Canada

18. ICON Laboratory Services, Whitesboro, New York, USA

19. KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA

20. Keystone Bioanalytical, Lansdale, Pennsylvania, USA

21. Labcorp, Madison, Wisconsin, USA

22. Labcorp, Indianapolis, Indiana, USA

23. LGC, Ely, UK

24. Mercodia, Uppsala, Sweden

25. Nexelis - a Q2 Solutions Company, Seattle, Washington, USA

26. Pharmaron, Germantown, Maryland, USA

27. PPD Laboratories, Richmond, Virginia, USA

28. Pyxant Labs, Colorado Springs, Colorado, USA

29. Pyxant Labs, Salt Lake City, Utah, USA

30. Syneos Health, Princeton, New Jersey, USA

31. WuXi AppTec, Plainsboro, New Jersey, USA

Abstract

Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of qPCR and a complete lack of any regulatory guidelines for the use of the newer ddPCR to support regulated bioanalysis. Hence, the Global CRO Council in Bioanalysis (GCC) has issued this White Paper to provide; 1) a consensus on the different validation parameters required to support qPCR/ddPCR assays; 2) a harmonized approach to their validation and 3) a consistent development of standard operating procedures (SOPs) for all the bioanalytical laboratories using these techniques.

Publisher

Future Science Ltd

Subject

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

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