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Recommendations on ELISpot assay validation by the GCC.
Islam, Rafiq; Vance, Jennifer; Poirier, Martin; Zimmer, Jennifer; Khadang, Ardeshir; Williams, Dave; Zemo, Jennifer; Lester, Todd; Fjording, Marianne; Hays, Amanda; Hughes, Nicola; Garofolo, Fabio; Sheldon, Curtis; Guilbaud, Rudolf; Satterwhite, Christina; Colletti, Kelly; Groeber, Elizabeth; Renfrew, Heidi; Yu, Mathilde; Lin, Jenny; Fang, Xinping; Wissel, Mark; Beadnell, Thomas; Lin, John; Shah, Santosh; Garofolo, Wei; Savoie, Natasha; Hayes, Roger; Pirro, John; Kane, Cheikh; Luna, Marsha; Xu, Allan; Cape, Stephanie; O'Dell, Mark; Wheller, Robert; Ritzen, Hanna; Farley, Esme; Kierstead, Lisa; Mylott, William; Tabler, Edward; Yuan, Moucun; Karnik, Shane; Voelker, Troy; DuBey, Ira; Williard, Clark; Dong, Kelly; Shi, Jing; Yamashita, Jim.
Afiliación
  • 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.
Bioanalysis ; 14(4): 187-193, 2022 Feb.
Article en En | MEDLINE | ID: mdl-35135309
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.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Bioensayo / Terapia Genética / Ensayo de Immunospot Ligado a Enzimas / Tratamiento Basado en Trasplante de Células y Tejidos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
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PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Bioensayo / Terapia Genética / Ensayo de Immunospot Ligado a Enzimas / Tratamiento Basado en Trasplante de Células y Tejidos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos