Recommendations on ELISpot assay validation by the GCC.

Autor: Islam R; Smithers, Gaithersburg, MD, USA., Vance J; AIT Bioscience - a Nexelis Company, Seattle, WA, USA., Poirier M; Altasciences, Everett, WA, USA., Zimmer J; Alturas Analytics, Moscow, ID, USA., Khadang A; Axis Clinical, Dilworth, MN, USA., Williams D; BioAgilytix, Durham, NC, USA., Zemo J; BioAgilytix, Durham, NC, USA., Lester T; BioAgilytix, Durham, NC, USA., Fjording M; BioAgilytix, Durham, NC, USA., Hays A; BioAgilytix, Durham, NC, USA., Hughes N; Biopharmaservices, Toronto, ON, Canada., Garofolo F; BRI - a Frontage Company, Vancouver, BC, Canada., Sheldon C; Celerion, Lincoln, NE, USA., Guilbaud R; CellCarta, Montreal, Quebec, Canada., Satterwhite C; Charles River Laboratories, Reno, NV, USA., Colletti K; Charles River Laboratories, Reno, NV, USA., Groeber E; Charles River Laboratories, Ashland, OH, USA., Renfrew H; Charles River Laboratories, Shrewsbury, MA, USA., Yu M; CIRION, Montreal, Quebec, Canada., Lin J; CMIC, Hoffman Estates, IL, USA., Fang X; CR Medicon, Piscataway, NJ, USA., Wissel M; Eurofins Virocor, Lee's Summit, MO, USA., Beadnell T; Eurofins Virocor, Lee's Summit, MO, USA., Lin J; Frontage Laboratories, Exton, PA, USA., Shah S; Frontage Laboratories, Exton, PA, USA., Garofolo W; GCC, Toronto, ON, Canada., Savoie N; GCC, Toronto, ON, Canada., Hayes R; ICON Laboratory Services, Whitesboro, NY, USA., Pirro J; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Kane C; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA., Xu A; Keystone Bioanalytical, Lansdale, PA, USA., Cape S; Labcorp, Madison, WI, USA., O'Dell M; Labcorp, Indianapolis, IN, USA., Wheller R; LGC, Ely, UK., Ritzen H; Mercodia, Uppsala, Sweden., Farley E; Pharmaron, Germantown, MD, USA., Kierstead L; PPD Laboratories, Wayne, PA, USA., Mylott W; PPD Laboratories, Richmond, VA, USA., Tabler E; PPD Laboratories, Richmond, VA, USA., Yuan M; PPD Laboratories, Richmond, VA, USA., Karnik S; Pyxant Labs, Colorado Springs, CO, USA., Voelker T; Pyxant Labs, Salt Lake City, UT, USA., DuBey I; Smithers, Gaithersburg, MD, USA., Williard C; Syneos Health, Princeton, NJ, USA., Dong K; United-Power Pharma, Beijing, China., Shi J; WuXi AppTec, Plainsboro, NJ, USA., Yamashita J; WuXi AppTec, Plainsboro, NJ, USA.
Jazyk: angličtina
Zdroj: Bioanalysis [Bioanalysis] 2022 Feb; Vol. 14 (4), pp. 187-193.
DOI: 10.4155/bio-2022-0010
Abstrakt: 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.
Databáze: MEDLINE