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Identification and Characterization of Polysorbate-Degrading Enzymes in a Monoclonal Antibody Formulation.
Graf, Tobias; Tomlinson, Anthony; Yuk, Inn H; Kufer, Regina; Spensberger, Bernhard; Falkenstein, Roberto; Shen, Amy; Li, Hong; Duan, Dana; Liu, Wenqiang; Wohlrab, Stefanie; Edelmann, Franziska; Leiss, Michael.
Afiliación
  • Graf T; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany. Electronic address: Tobias.Graf@roche.com.
  • Tomlinson A; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Yuk IH; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Kufer R; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
  • Spensberger B; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
  • Falkenstein R; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
  • Shen A; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Li H; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Duan D; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Liu W; Pharma Technical Development, Genentech, 1 DNA Way, South San Francisco, California, USA.
  • Wohlrab S; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
  • Edelmann F; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
  • Leiss M; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany.
J Pharm Sci ; 110(11): 3558-3567, 2021 Nov.
Article en En | MEDLINE | ID: mdl-34224732
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Polisorbatos / Anticuerpos Monoclonales Tipo de estudio: Diagnostic_studies Idioma: En Revista: J Pharm Sci Año: 2021 Tipo del documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Polisorbatos / Anticuerpos Monoclonales Tipo de estudio: Diagnostic_studies Idioma: En Revista: J Pharm Sci Año: 2021 Tipo del documento: Article