Recommendations on ELISpot assay validation by the GCC

Author:

Islam Rafiq1,Vance Jennifer2,Poirier Martin3,Zimmer Jennifer4,Khadang Ardeshir5,Williams Dave6,Zemo Jennifer6,Lester Todd6,Fjording Marianne6,Hays Amanda6,Hughes Nicola7,Garofolo Fabio8,Sheldon Curtis9,Guilbaud Rudolf10,Satterwhite Christina11,Colletti Kelly11,Groeber Elizabeth12,Renfrew Heidi13,Yu Mathilde14,Lin Jenny15,Fang Xinping16,Wissel Mark17,Beadnell Thomas17,Lin John18,Shah Santosh18,Garofolo Wei19,Savoie Natasha19,Hayes Roger20,Pirro John21,Kane Cheikh21,Luna Marsha21,Xu Allan22,Cape Stephanie23,O'Dell Mark24,Wheller Robert25,Ritzen Hanna26,Farley Esme27,Kierstead Lisa28,Mylott William29,Tabler Edward29,Yuan Moucun29,Karnik Shane30,Voelker Troy31,DuBey Ira1,Williard Clark32,Dong Kelly33,Shi Jing34,Yamashita Jim34

Affiliation:

1. Smithers, Gaithersburg, MD, USA

2. AIT Bioscience – a Nexelis Company, Seattle, WA, USA

3. Altasciences, Everett, WA, USA

4. Alturas Analytics, Moscow, ID, USA

5. Axis Clinical, Dilworth, MN, USA

6. BioAgilytix, Durham, NC, USA

7. Biopharmaservices, Toronto, ON, Canada

8. BRI – a Frontage Company, Vancouver, BC, Canada

9. Celerion, Lincoln, NE, USA

10. CellCarta, Montreal, Quebec, Canada

11. Charles River Laboratories, Reno, NV, USA

12. Charles River Laboratories, Ashland, OH, USA

13. Charles River Laboratories, Shrewsbury, MA, USA

14. CIRION, Montreal, Quebec, Canada

15. CMIC, Hoffman Estates, IL, USA

16. CR Medicon, Piscataway, NJ, USA

17. Eurofins Virocor, Lee's Summit, MO, USA

18. Frontage Laboratories, Exton, PA, USA

19. GCC, Toronto, ON, Canada

20. ICON Laboratory Services, Whitesboro, NY, USA

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

22. Keystone Bioanalytical, Lansdale, PA, USA

23. Labcorp, Madison, WI, USA

24. Labcorp, Indianapolis, IN, USA

25. LGC, Ely, UK

26. Mercodia, Uppsala, Sweden

27. Pharmaron, Germantown, MD, USA

28. PPD Laboratories, Wayne, PA, USA

29. PPD Laboratories, Richmond, VA, USA

30. Pyxant Labs, Colorado Springs, CO, USA

31. Pyxant Labs, Salt Lake City, UT, USA

32. Syneos Health, Princeton, NJ, USA

33. United-Power Pharma, Beijing, China

34. WuXi AppTec, Plainsboro, NJ, USA

Abstract

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.

Publisher

Future Science Ltd

Subject

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

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