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Subvisible (2-100 µm) particle analysis during biotherapeutic drug product development: Part 2, experience with the application of subvisible particle analysis.
Corvari, Vincent; Narhi, Linda O; Spitznagel, Thomas M; Afonina, Nataliya; Cao, Shawn; Cash, Patricia; Cecchini, Irene; DeFelippis, Michael R; Garidel, Patrick; Herre, Andrea; Koulov, Atanas V; Lubiniecki, Tony; Mahler, Hanns-Christian; Mangiagalli, Paolo; Nesta, Douglas; Perez-Ramirez, Bernardo; Polozova, Alla; Rossi, Mara; Schmidt, Roland; Simler, Robert; Singh, Satish; Weiskopf, Andrew; Wuchner, Klaus.
Afiliação
  • Corvari V; Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: corvarivj@lilly.com.
  • Narhi LO; Amgen, Process Development, Thousand Oaks, CA, USA.
  • Spitznagel TM; Human Genome Sciences, Inc., Rockville, MD, USA.
  • Afonina N; Bristol-Myers Squibb, Molecular and Analytical Development, NJ, USA.
  • Cao S; Amgen, Process Development, Thousand Oaks, CA, USA.
  • Cash P; MedImmune, Gaithersburg, MD, USA.
  • Cecchini I; Merck Serono Guidonia Site, Rome, Italy.
  • DeFelippis MR; Eli Lilly and Company, Indianapolis, IN, USA.
  • Garidel P; Boehringer Ingelheim Pharma GmbH & Co. KG, Biopharmaceuticals, 88397 Biberach an der Riss, Germany.
  • Herre A; Boehringer Ingelheim Pharma GmbH & Co. KG, Biopharmaceuticals, 88397 Biberach an der Riss, Germany.
  • Koulov AV; F. Hoffmann-La Roche Ltd, Pharma Technical Development Europe (Biologics) Analytical Development, 4070 Basel, Switzerland.
  • Lubiniecki T; Janssen R&D LLC, Malvern, PA, USA.
  • Mahler HC; F. Hoffmann-La Roche Ltd, Pharma Technical Development Europe (Biologics) Pharmaceutical Development and Supplies, 4070 Basel, Switzerland.
  • Mangiagalli P; BD Medical - Pharmaceutical Systems, 11, rue Aristide Bergès BP4, 38801 CEDEX Pont de Claix, France.
  • Nesta D; GlaxoSmithKline, King of Prussia, PA, USA.
  • Perez-Ramirez B; Genzyme Corporation, Framingham, MA, USA.
  • Polozova A; MedImmune, Gaithersburg, MD, USA.
  • Rossi M; Merck Serono Guidonia Site, Rome, Italy.
  • Schmidt R; F. Hoffmann-La Roche Ltd, Pharma Technical Development Europe (Biologics) Pharmaceutical Development and Supplies, 4070 Basel, Switzerland.
  • Simler R; Biogen Idec, Cambridge, MA, USA.
  • Singh S; Pfizer Inc, Chesterfield, MO, USA.
  • Weiskopf A; Biogen Idec, Cambridge, MA, USA.
  • Wuchner K; Janssen R&D, Schaffhausen, Switzerland.
Biologicals ; 43(6): 457-73, 2015 Nov.
Article em En | MEDLINE | ID: mdl-26324466
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas / Material Particulado / Nefelometria e Turbidimetria Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2015 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas / Material Particulado / Nefelometria e Turbidimetria Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2015 Tipo de documento: Article