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Recommendations on qPCR/ddPCR assay validation by GCC.
Wissel, Mark; Poirier, Martin; Satterwhite, Christina; Lin, John; Islam, Rafiq; Zimmer, Jennifer; Khadang, Ardeshir; Zemo, Jennifer; Lester, Todd; Fjording, Marianne; Hays, Amanda; Hughes, Nicola; Garofolo, Fabio; Guilbaud, Rudolf; Groeber, Elizabeth; Renfrew, Heidi; Colletti, Kelly; Yu, Mathilde; Lin, Jenny; Fang, Xinping; Shah, Santosh; Garofolo, Wei; Kar, Sumit; Hayes, Roger; Pirro, John; Kane, Cheikh; Luna, Marsha; Xu, Allan; Cape, Stephanie; O'Dell, Mark; Wheller, Robert; Ritzen, Hanna; Vance, Jennifer; Farley, Esme; Matys, Katie; Tabler, Edward; Mylott, William; Yuan, Moucun; Karnik, Shane; Voelker, Troy; DuBey, Ira; Williard, Clark; Shi, Jing; Yamashita, Jim.
Afiliación
  • Wissel M; Eurofins Viracor BioPharma, Lenexa,Kansas, USA.
  • Poirier M; Altasciences, Everett, Washington, USA.
  • Satterwhite C; Charles River Laboratories, Reno, Nevada, USA.
  • Lin J; Frontage Laboratories, Exton, Pennsylvania, USA.
  • Islam R; Smithers, Gaithersburg, Maryland, USA.
  • Zimmer J; Alturas Analytics, Moscow, Idaho, USA.
  • Khadang A; Axis Clinical, Dilworth, Minnesota, USA.
  • Zemo J; BioAgilytix, Durham, North Carolina, USA.
  • Lester T; BioAgilytix, Durham, North Carolina, USA.
  • Fjording M; BioAgilytix, Durham, North Carolina, USA.
  • Hays A; BioAgilytix, Durham, North Carolina, USA.
  • Hughes N; Biopharmaservices, Toronto, Ontario, Canada.
  • Garofolo F; BRI - a Frontage Company, Vancouver, British Columbia, Canada.
  • Guilbaud R; CellCarta, Montreal, Quebec, Canada.
  • Groeber E; Charles River Laboratories, Ashland, Ohio, USA.
  • Renfrew H; Charles River Laboratories, Shrewsbury, Massachusetts, USA.
  • Colletti K; Charles River Laboratories, Reno, Nevada, USA.
  • Yu M; CIRION, Montreal, Quebec, Canada.
  • Lin J; CMIC, Hoffman Estates, Illinois, USA.
  • Fang X; CR Medicon, Piscataway, New Jersey, USA.
  • Shah S; Frontage Laboratories, Exton, Pennsylvania, USA.
  • Garofolo W; GCC, Toronto, Ontario, Canada.
  • Kar S; GCC, Toronto, Ontario, Canada.
  • Hayes R; ICON Laboratory Services, Whitesboro, New York, USA.
  • Pirro J; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Kane C; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Luna M; KCAS Bioanalytical & Biomarker Services, Shawnee Mission, Kansas, USA.
  • Xu A; Keystone Bioanalytical, Lansdale, Pennsylvania, USA.
  • Cape S; Labcorp, Madison, Wisconsin, USA.
  • O'Dell M; Labcorp, Indianapolis, Indiana, USA.
  • Wheller R; LGC, Ely, UK.
  • Ritzen H; Mercodia, Uppsala, Sweden.
  • Vance J; Nexelis - a Q2 Solutions Company, Seattle, Washington, USA.
  • Farley E; Pharmaron, Germantown, Maryland, USA.
  • Matys K; PPD Laboratories, Richmond, Virginia, USA.
  • Tabler E; PPD Laboratories, Richmond, Virginia, USA.
  • Mylott W; PPD Laboratories, Richmond, Virginia, USA.
  • Yuan M; PPD Laboratories, Richmond, Virginia, USA.
  • Karnik S; Pyxant Labs, Colorado Springs, Colorado, USA.
  • Voelker T; Pyxant Labs, Salt Lake City, Utah, USA.
  • DuBey I; Smithers, Gaithersburg, Maryland, USA.
  • Williard C; Syneos Health, Princeton, New Jersey, USA.
  • Shi J; WuXi AppTec, Plainsboro, New Jersey, USA.
  • Yamashita J; WuXi AppTec, Plainsboro, New Jersey, USA.
Bioanalysis ; 14(12): 853-863, 2022 Jun.
Article en En | MEDLINE | ID: mdl-35703321
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.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bioensayo Tipo de estudio: Guideline Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Bioensayo Tipo de estudio: Guideline Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos