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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Loo, Lina; Harris, Shannon; Milton, Mark; Lembke, Wibke; Berisha, Flora; Bertholet, Sylvie; Dessy, Francis; Dodge, Robert; Fang, Xiaodong; Fiscella, Michele; Garofolo, Fabio; Gorovits, Boris; Gupta, Soumi; Jawa, Vibha; Ishii-Watabe, Akiko; Long, Brian; Lu, Yanmei; Mack, Timothy; McGuire, Kristina; Nolan, Katrina; Pan, Luying; Potthoff, Bernd; Purushothama, Shobha; Smith, Dean; Solstad, Therese; Sonderegger, Ivo; Taddeo, Frank; Tangri, Shabnam; Wagner, Leslie; Wu, Bonnie; Xu, Yuanxin; Kirshner, Susan; Verthelyi, Daniela; Yan, Haoheng; Maxfield, Kimberly; Pedras-Vasconcelos, Joao; Abhari, Mohsen Rajabi; Gupta, Swati; Wu, Yuling; Rajadhyaksha, Manoj; Andisik, Matthew; Baltrukonis, Daniel; Cherry, Elana; Cludts, Isabelle; Gunn, George; Millner, Anders Holm; Jordan, Gregor; Kar, Sumit; Kubiak, Robert; Lotz, Gregor P.
Afiliación
  • Loo L; Vertex, Boston, MA.
  • Harris S; HilleVax, Cambridge, MA, USA.
  • Milton M; Novartis, Cambridge, MA, USA.
  • Meena; Stoke, Cambridge, MA, USA.
  • Lembke W; UCB Farchim SA, Bulle, Switzerland.
  • Berisha F; Janssen R&D, Spring House, PA, USA.
  • Bertholet S; GlaxoSmithKline Vaccines, Rockville, MD, USA.
  • Dessy F; GlaxoSmithKline, Rixensart, Belgium.
  • Dodge R; Novartis, East Hanover, NJ, USA.
  • Fang X; AskBio, Research Triangle Park, NC, USA.
  • Fiscella M; REGENXBIO, Rockville, MD, USA.
  • Garofolo F; BRI - a Frontage company, Vancouver, BC, Canada.
  • Gorovits B; Sana Bio, Cambridge, MA, USA.
  • Gupta S; BioMarin, Novato, CA, USA.
  • Jawa V; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan.
  • Long B; BioMarin, Novato, CA, USA.
  • Lu Y; Sangamo, Brisbane, CA, USA.
  • Mack T; Bristol-Myers Squibb, Lawrenceville, NJ, USA.
  • McGuire K; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Nolan K; Merck, West Point, PA, USA.
  • Pan L; Takeda, Cambridge, MA, USA.
  • Potthoff B; Novartis, Basel, Switzerland.
  • Purushothama S; WRIB, Montreal, QC, Canada.
  • Smith D; Health Canada, Ottawa, ON, Canada.
  • Solstad T; Norwegian Medicines Agency, Oslo, Norway.
  • Sonderegger I; Takeda, Opfikon, Switzerland.
  • Taddeo F; Takeda, Cambridge, MA, USA.
  • Tangri S; Navigate, a Novartis Subsidiary, San Diego, CA, USA.
  • Wagner L; US FDA, Silver Spring, MD, USA.
  • Wu B; Janssen R&D, Spring House, PA, USA.
  • Xu Y; Intellia, Cambridge, MA, USA.
  • Kirshner S; US FDA, Silver Spring, MD, USA.
  • Verthelyi D; US FDA, Silver Spring, MD, USA.
  • Yan H; US FDA, Silver Spring, MD, USA.
  • Maxfield K; US FDA, Silver Spring, MD, USA.
  • Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA.
  • Abhari MR; US FDA, Silver Spring, MD, USA.
  • Gupta S; AbbVie, Irvine, CA, USA.
  • Wu Y; AstraZeneca, Gaithersburg, MD, USA.
  • Rajadhyaksha M; Alexion, New Haven, CT, USA.
  • Andisik M; Regeneron Pharmaceuticals, Tarrytown, NY, USA.
  • Baltrukonis D; Pfizer, Groton, CT, USA.
  • Cherry E; Health Canada, Ottawa, ON, Canada.
  • Cludts I; UK MHRA, London, UK.
  • Gunn G; GlaxoSmithKline, Collegeville, PA, USA.
  • Millner AH; Novo Nordisk, Maaloev, Denmark.
  • Jordan G; Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
  • Kar S; WRIB, Montreal, QC, Canada.
  • Kubiak R; AstraZeneca, Gaithersburg, MD, USA.
Bioanalysis ; 14(11): 737-793, 2022 Jun.
Article en En | MEDLINE | ID: mdl-35578991
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vacunas / Receptores Quiméricos de Antígenos Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Marruecos
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Vacunas / Receptores Quiméricos de Antígenos Tipo de estudio: Guideline / Qualitative_research Límite: Humans Idioma: En Revista: Bioanalysis Año: 2022 Tipo del documento: Article País de afiliación: Marruecos