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Report of the 2019 NIST-FDA workshop on standards for next generation sequencing detection of viral adventitious agents in biologics and biomanufacturing.
Cleveland, Megan H; Anekella, Bharathi; Brewer, Michael; Chin, Pei-Ju; Couch, Heather; Delwart, Eric; Huggett, Jim; Jackson, Scott; Martin, Javier; Monpoeho, Serge; Morrison, Tom; Ng, Siemon H S; Ussery, David; Khan, Arifa S.
Afiliação
  • Cleveland MH; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD, 20899, USA.
  • Anekella B; LGC-Clinical Diagnostic Business Unit, 910 Clopper Road, Gaithersburg, MD, 20878, USA.
  • Brewer M; Thermo Fisher Scientific, 35 Wiggins Ave, Bedford, MA, 01730, USA.
  • Chin PJ; Center for Biologics Research and Evaluation, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Couch H; American Type Culture Collection, 10801 University Boulevard, Manassas, VA, 20110, USA.
  • Delwart E; Vitalant Research Institute, 270 Masonic Ave, San Francisco, CA, 94118, USA.
  • Huggett J; National Measurement Laboratory at LGC, Queens Road, Teddington, TW11 0LY, UK; School of Biosciences & Medicine, Faculty of Health & Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, UK.
  • Jackson S; National Institute of Standards and Technology, 100 Bureau Dr, Gaithersburg, MD, 20899, USA.
  • Martin J; National Institute for Biological Standards and Control, Blanche Ln, South Mimms, Potters Bar, EN6 3QG, UK.
  • Monpoeho S; Regeneron Pharmaceuticals, 81 Columbia Turnpike, Rensselaer, NY, 12144, USA.
  • Morrison T; AccuGenomics, 1410 Commonwealth Dr. Ste. 105, Wilmington, NC, 28403, USA.
  • Ng SHS; Analytical Sciences, Sanofi Pasteur, Analytical Research and Development, 1755, Steeles Avenue West, M2R 3T4, Toronto, Ontario, Canada.
  • Ussery D; Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock, AR, 72205, USA.
  • Khan AS; Center for Biologics Research and Evaluation, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Electronic address: arifa.khan@fda.hhs.gov.
Biologicals ; 64: 76-82, 2020 Mar.
Article em En | MEDLINE | ID: mdl-32094072
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vírus / Produtos Biológicos / Contaminação de Medicamentos / Sequenciamento de Nucleotídeos em Larga Escala Tipo de estudo: Diagnostic_studies / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Vírus / Produtos Biológicos / Contaminação de Medicamentos / Sequenciamento de Nucleotídeos em Larga Escala Tipo de estudo: Diagnostic_studies / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Estados Unidos