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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Corsaro, Bart; Yang, Tong-Yuan; Murphy, Rocio; Sonderegger, Ivo; Exley, Andrew; Bertholet, Sylvie; Dakappagari, Naveen; Dessy, Francis; Garofolo, Fabio; Kierstead, Lisa; Koch, Holger; Sarikonda, Ghanashyam; Savoie, Natasha; Siggers, Richard; Solstad, Therese; Lu, Yanmei; Milton, Mark; Marshall, Jean-Claude; DelCarpini, Jason; Gorovits, Boris; Gupta, Swati; Jesaitis, Lynne; Kamerud, John; Kromminga, Arno; Ma, Anna; McNally, Jim; Yan, Haoheng; Wu, Bonnie; Verthelyi, Daniela; Kirshner, Susan; Pedras-Vasconcelos, Joao; Rajadhyaksha, Manoj; Staack, Roland F; Cherry, Elana; Cludts, Isabelle; Dahlbäck, Madeleine; Gunn, George R; Ishii-Watabe, Akiko; Jawa, Vibha; Kubiak, Robert; Partridge, Michael; Petrillo, Marco; Pine, Samuel O; Poetzl, Johann; Song, Sam; Stebbins, Chris; Wu, Yuling; Zhang, Lucia; Kar, Sumit; Liang, Meina.
Afiliação
  • Corsaro B; GlaxoSmithKline, Rockville, MD, USA.
  • Yang TY; Janssen R&D, Spring House, PA, USA.
  • Murphy R; Merck, West Point, PA, USA.
  • Sonderegger I; Takeda, Opfikon, Switzerland.
  • Exley A; UK MHRA, London, UK.
  • Bertholet S; GlaxoSmithKline, Rockville, MD, USA.
  • Dakappagari N; Navigate, a Novartis Subsidiary, San Diego, CA, USA.
  • Dessy F; GlaxoSmithKline, Rixensart, Belgium.
  • Garofolo F; BRI, Vancouver, BC, Canada.
  • Kierstead L; PPD, Wayne, PA, USA.
  • Koch H; Takeda, Opfikon, Switzerland.
  • Sarikonda G; Navigate, a Novartis Subsidiary, San Diego, CA, USA.
  • Savoie N; CFABS, Montreal, QC, Canada.
  • Siggers R; Health Canada, Ottawa, ON, Canada.
  • Solstad T; Norwegian Medicines Agency, Oslo, Norway.
  • Lu Y; Sangamo Therapeutics, Brisbane, CA, USA.
  • Milton M; Novartis, Cambridge, MA, USA.
  • Marshall JC; Pfizer, Groton, CT, USA.
  • DelCarpini J; bluebird bio, Cambridge, MA, USA.
  • Gorovits B; Pfizer, Andover, MA, USA.
  • Gupta S; Abbvie, Irvine, CA, USA.
  • Jesaitis L; BioMarin, Novato, CA, USA.
  • Kamerud J; Pfizer, Andover, MA, USA.
  • Kromminga A; BioAgilytix, Hamburg, Germany.
  • Ma A; CRISPR Therapeutics, Cambridge, MA, USA.
  • McNally J; BioAgilytix, Durham, NC, USA.
  • Yan H; US FDA, Silver Spring, MD, USA.
  • Wu B; Janssen R&D, Spring House, PA, USA.
  • Verthelyi D; US FDA, Silver Spring, MD, USA.
  • Kirshner S; US FDA, Silver Spring, MD, USA.
  • Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA.
  • Rajadhyaksha M; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Staack RF; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Cherry E; Health Canada, Ottawa, ON, Canada.
  • Cludts I; UK MHRA-NIBSC, London, UK.
  • Dahlbäck M; Novo Nordisk, Maaloev, Denmark.
  • Gunn GR; GlaxoSmithKline, Collegeville, PA, USA.
  • Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan.
  • Jawa V; Merck, Kenilworth, NJ, USA.
  • Kubiak R; AstraZeneca, Gaithersburg, MD, USA.
  • Partridge M; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Petrillo M; Biogen, Cambridge, MA, USA.
  • Pine SO; Ablynx, Zwijnaarde, Belgium.
  • Poetzl J; Hexal AG, Oberhaching, Germany.
  • Song S; Takeda, Cambridge, MA, USA.
  • Stebbins C; Immunologix Labs, Tampa, FL, USA.
  • Wu Y; AstraZeneca, Gaithersburg, MD, USA.
  • Zhang L; Health Canada, Ottawa, ON, Canada.
  • Kar S; CFABS, Montreal, QC, Canada.
  • Liang M; AstraZeneca, South San Francisco, CA, USA.
Bioanalysis ; 13(6): 415-463, 2021 Mar.
Article em En | MEDLINE | ID: mdl-33533276
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas / Terapia Genética / Reação em Cadeia da Polimerase em Tempo Real / Terapia Baseada em Transplante de Células e Tecidos / Citometria de Fluxo Tipo de estudo: Guideline Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas / Terapia Genética / Reação em Cadeia da Polimerase em Tempo Real / Terapia Baseada em Transplante de Células e Tecidos / Citometria de Fluxo Tipo de estudo: Guideline Limite: Humans País/Região como assunto: America do norte Idioma: En Ano de publicação: 2021 Tipo de documento: Article