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Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products.
Blümel, Markus; Liu, Jing; de Jong, Isabella; Weiser, Sarah; Fast, Jonas; Litowski, Jennifer; Shuman, Melissa; Mehta, Shyam B; Amery, Leanne; Tan, David Cheng Thiam; Jia, Feng; Shekhawat, Dushyant; Dagallier, Camille; Emamzadeh, Mina; Medina, Annette; Santos, Camilla; Gasser, Florian; Urban, Christian.
Afiliación
  • Blümel M; Novartis Pharma AG, Biologics Analytical Development, Lichtstrasse 35, CH-4056 Basel, Switzerland. Electronic address: markus.bluemel@novartis.com.
  • Liu J; Seagen Inc., Pharmaceutical Sciences, 21717 30th Drive S.E., Building 3. Bothell, WA, 98021, USA. Electronic address: liujing97@gmail.com.
  • de Jong I; Genentech (A Member of the Roche Group), Pharmaceutical Development, 1 DNA Way, South San Francisco, CA, 94080, USA.
  • Weiser S; Pfizer; Biotherapeutics Pharmaceutical Sciences, 1 Burtt Road, Andover, MA 01810, USA.
  • Fast J; F. Hoffmann-La Roche Ltd., Pharmaceutical Development & Supplies, PTD Biologics Europe, Grenzacherstrasse 124, CH, 4070 Basel, Switzerland.
  • Litowski J; Amgen Inc., Process Development, 360 Binney St., Cambridge, MA, 02141, USA.
  • Shuman M; GSK, Strategic External Development, Sterile Drug Product Operations, 1250 S. Collegeville Road Collegeville, PA, 19426, USA.
  • Mehta SB; Teva Branded Pharmaceutical Products, Drug Product Development and Operations, 145 Brandywine Pkwy, West Chester, PA 19380, USA.
  • Amery L; AstraZeneca, Dosage Form Design and Development, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK.
  • Tan DCT; AbbVie Inc., North Chicago, IL, USA.
  • Jia F; Biogen, Biologics Drug Product, 225 Binney Street, Cambridge, MA, 02142, USA.
  • Shekhawat D; Eli Lilly and Company, Bioproduct Research and Development, Indianapolis, IN, 46285, USA.
  • Dagallier C; Sanofi, Biologics Drug Product Development, 1 impasse des ateliers, 94403 Vitry-Sur-Seine, France.
  • Emamzadeh M; AstraZeneca, Dosage Form Design and Development, Aaron Klug Building, Granta Park, Cambridge, Cambridgeshire, CB21 6GH, UK.
  • Medina A; AstraZeneca, Dosage Form Design and Development, One Medimmune Way, Gaithersburg, MD, 20878, USA.
  • Santos C; Amgen Inc., Product Quality, 40 Technology Way, West Greenwich, RI, 02817, USA.
  • Gasser F; Novartis Pharma AG, Biologics Analytical Development, Biochemiestrasse 10, 6336 Langkampfen, Austria.
  • Urban C; Sanofi, Biologics Drug Product Development, Industriepark Höchst, D-65926 Frankfurt am Main, Germany.
J Pharm Sci ; 112(9): 2332-2346, 2023 09.
Article en En | MEDLINE | ID: mdl-37160227
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Tipo de estudio: Guideline Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article
Texto completo
Añadir a Mi BVS
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos Tipo de estudio: Guideline Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article