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Holistic analytical characterization and risk assessment of residual host cell protein impurities in an active pharmaceutical ingredient synthesized by biocatalysts.
Wang, Fengqiang; Li, Xuanwen; Swanson, Michael; Guetschow, Erik; Winston, Matthew; Smith, Joseph P; Hoyt, Erik; Liu, Zhijian; Richardson, Douglas; Bu, Xiaodong; Jawa, Vibha; Variankaval, Narayan.
Afiliação
  • Wang F; Small Molecule Analytical Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Li X; Biologics Analytical Research & Development, Merck & Co. Inc., Kenilworth, New Jersey, USA.
  • Swanson M; Analytical Enabling Technologies, Analytical Research & Development, Merck & Co. Inc., Kenilworth, New Jersey, USA.
  • Guetschow E; Pharmcokinetics, Pharmcodynamics & Drug Metabolism (PPDM), Merck & Co. Inc., West Point, Pennsylvania, USA.
  • Winston M; Small Molecule Analytical Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Smith JP; Small Molecule Process Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Hoyt E; Analytical Enabling Technologies, Analytical Research & Development, Merck & Co. Inc., Kenilworth, New Jersey, USA.
  • Liu Z; Small Molecule Analytical Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Richardson D; Small Molecule Process Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Bu X; Analytical Enabling Technologies, Analytical Research & Development, Merck & Co. Inc., Kenilworth, New Jersey, USA.
  • Jawa V; Small Molecule Analytical Research & Development, Merck & Co. Inc., Rahway, New Jersey, USA.
  • Variankaval N; Pharmcokinetics, Pharmcodynamics & Drug Metabolism (PPDM), Merck & Co. Inc., West Point, Pennsylvania, USA.
Biotechnol Bioeng ; 119(8): 2088-2104, 2022 08.
Article em En | MEDLINE | ID: mdl-35437754
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Proteínas Tipo de estudo: Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2022 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Proteínas Tipo de estudo: Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2022 Tipo de documento: Article