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Industry Perspective on the Use and Characterization of Polysorbates for Biopharmaceutical Products Part 2: Survey Report on Control Strategy Preparing for the Future.
Wuchner, Klaus; Yi, Linda; Chery, Cyrille; Nikels, Felix; Junge, Friederike; Crotts, George; Rinaldi, Gianluca; Starkey, Jason A; Bechtold-Peters, Karoline; Shuman, Melissa; Leiss, Michael; Jahn, Michael; Garidel, Patrick; de Ruiter, Rien; Richer, Sarah M; Cao, Shawn; Peuker, Sebastian; Huille, Sylvain; Wang, Tingting; Brun, Virginie Le.
Afiliación
  • Wuchner K; Janssen R&D, DPDS BTDS Analytical Development, Hochstr. 201, 8200 Schaffhausen, Switzerland. Electronic address: kwuchne1@its.jnj.com.
  • Yi L; Analytical Development, Biogen, Morrisville, NC 27709, USA.
  • Chery C; UCB, Analytical Development Sciences for Biologicals, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium.
  • Nikels F; Boehringer Ingelheim Pharma GmbH & Co KG, Innovation Unit, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany.
  • Junge F; Analytical Research and Development, NBE Analytical R&D, AbbVie Deutschland GmbH& Co. KG, Knollstraße, 67061 Ludwigshafen, Germany.
  • Crotts G; GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, USA.
  • Rinaldi G; Merck Serono SpA, Guidonia Montecelio, Italy, an affiliate of Merck KGaA, Darmstadt, Germany.
  • Starkey JA; Pfizer, Inc. Biotherapeutics Pharmaceutical Sciences, Analytical Research and Development 875 W. Chesterfield Parkway, Chesterfield, MO 63017, USA.
  • Bechtold-Peters K; Novartis Pharma AG, TRD Biologics & CGT, GDD, 4002 Basel, Switzerland.
  • Shuman M; GlaxoSmithKline, 1250 S Collegeville Rd, Collegeville, PA 19426, USA.
  • Leiss M; Pharma Technical Development Analytics, Roche Diagnostics GmbH, Nonnenwald 2, Penzberg, 82377, Germany.
  • Jahn M; Lonza AG, Drug Product Services, Hochbergerstr. 60G, CH-4057 Basel, Switzerland.
  • Garidel P; Boehringer Ingelheim Pharma GmbH & Co KG, Innovation Unit, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany.
  • de Ruiter R; Byondis B.V., Downstream Processing, Nijmegen, the Netherlands.
  • Richer SM; Bioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Cao S; Process Development, Amgen Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320, USA.
  • Peuker S; Bayer AG, Product Supply, Analytical Development and Clinical QC for Biotech Products, Friedrich-Ebert-Str. 217-233, 42117 Wuppertal, Germany.
  • Huille S; Sanofi R&D, Biologics Drug Products Development,13 quai Jules Guesde, 94403 Vitry-sur Seine, France.
  • Wang T; Bioproduct Research and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA.
  • Brun VL; Lonza AG, Drug Product Services, Hochbergerstr. 60G, CH-4057 Basel, Switzerland.
J Pharm Sci ; 111(11): 2955-2967, 2022 11.
Article en En | MEDLINE | ID: mdl-36002077
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polisorbatos / Productos Biológicos Idioma: En Revista: J Pharm Sci Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Polisorbatos / Productos Biológicos Idioma: En Revista: J Pharm Sci Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos