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End-to-end collaboration to transform biopharmaceutical development and manufacturing.
Erickson, John; Baker, Jeffrey; Barrett, Shawn; Brady, Ciaran; Brower, Mark; Carbonell, Ruben; Charlebois, Tim; Coffman, Jon; Connell-Crowley, Lisa; Coolbaugh, Michael; Fallon, Eric; Garr, Eric; Gillespie, Christopher; Hart, Roger; Haug, Allison; Nyberg, Gregg; Phillips, Michael; Pollard, David; Qadan, Maen; Ramos, Irina; Rogers, Kelley; Schaefer, Gene; Walther, Jason; Lee, Kelvin.
Afiliação
  • Erickson J; National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware, USA.
  • Baker J; Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
  • Barrett S; Global CMC Development, Sanofi, Framingham, Massachusetts, USA.
  • Brady C; Biologics MS&T, Bristol-Myers Squibb, Devens, Massachusetts, USA.
  • Brower M; Biologics Process Research and Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Carbonell R; National Institute for Innovation in Manufacturing Biopharmaceuticals, Raleigh, North Carolina, USA.
  • Charlebois T; BioTx Pharmaceutical Sciences, Pfizer, Andover, Massachusetts, USA.
  • Coffman J; Biopharmaceutical Development, AstraZeneca, Gaithersburg, Maryland, USA.
  • Connell-Crowley L; Process Design, Just-Evotec Biologics, Seattle, Washington, USA.
  • Coolbaugh M; Global CMC Development, Sanofi, Framingham, Massachusetts, USA.
  • Fallon E; Manufacturing Science and Technology, Drug Substance, Genentech, Inc., Oceanside, California, USA.
  • Garr E; Biologics MS&T, Bristol-Myers Squibb, Devens, Massachusetts, USA.
  • Gillespie C; Biologics Process Research and Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Hart R; Process Development, Amgen, Cambridge, Massachusetts, USA.
  • Haug A; National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware, USA.
  • Nyberg G; Biologics Process Research and Development, Merck & Co., Inc., Kenilworth, New Jersey, USA.
  • Phillips M; Next Generation Processing R&D, MilliporeSigma, Bedford, Massachusetts, USA.
  • Pollard D; Sartorius Corporate Research, Sartorius, Boston, Massachusetts, USA.
  • Qadan M; Biologics Research and Development, Eli Lilly and Company, Indianapolis, Indiana, USA.
  • Ramos I; Biopharmaceutical Development, AstraZeneca, Gaithersburg, Maryland, USA.
  • Rogers K; Material Measurement Laboratory and Office of Advanced Manufacturing, National Institute of Standards and Technology, Gaithersburg, Maryland, USA.
  • Schaefer G; API Large Molecule BioTherapeutics Development, Janssen R&D, Malvern, Pennsylvania, USA.
  • Walther J; Global CMC Development, Sanofi, Framingham, Massachusetts, USA.
  • Lee K; National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware, USA.
Biotechnol Bioeng ; 118(9): 3302-3312, 2021 09.
Article em En | MEDLINE | ID: mdl-33480041

Texto completo: 1 Temas: ECOS / Estado_mercado_regulacao Bases de dados: MEDLINE Assunto principal: Produtos Biológicos / Tecnologia Farmacêutica / Indústria Farmacêutica Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Temas: ECOS / Estado_mercado_regulacao Bases de dados: MEDLINE Assunto principal: Produtos Biológicos / Tecnologia Farmacêutica / Indústria Farmacêutica Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos