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Impacts on product quality attributes of monoclonal antibodies produced in CHO cell bioreactor cultures during intentional mycoplasma contamination events.
Fratz-Berilla, Erica J; Angart, Phillip; Graham, Ryan J; Powers, David N; Mohammad, Adil; Kohnhorst, Casey; Faison, Talia; Velugula-Yellela, Sai Rashmika; Trunfio, Nicholas; Agarabi, Cyrus.
Afiliação
  • Fratz-Berilla EJ; Division of Biotechnology Review and Research II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Biotechnology Products, Silver Spring, Maryland.
  • Angart P; Division of Biotechnology Review and Research II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Biotechnology Products, Silver Spring, Maryland.
  • Graham RJ; Division of Product Quality Research, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, Silver Spring, Maryland.
  • Powers DN; Department of Chemical Engineering, University of Massachusetts Lowell, Lowell, Massachusetts.
  • Mohammad A; Division of Biotechnology Review and Research II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Biotechnology Products, Silver Spring, Maryland.
  • Kohnhorst C; Division of Product Quality Research, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, Silver Spring, Maryland.
  • Faison T; Nova Biomedical, Waltham, Massachusetts.
  • Velugula-Yellela SR; Division of Biotechnology Review and Research II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Biotechnology Products, Silver Spring, Maryland.
  • Trunfio N; Division of Biotechnology Review and Research II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Biotechnology Products, Silver Spring, Maryland.
  • Agarabi C; Sartorius Stedim Data Analytics, Bohemia, New York.
Biotechnol Bioeng ; 117(9): 2802-2815, 2020 09.
Article em En | MEDLINE | ID: mdl-32436993
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Técnicas de Cultura de Células / Reatores Biológicos / Anticorpos Monoclonais / Mycoplasma Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Técnicas de Cultura de Células / Reatores Biológicos / Anticorpos Monoclonais / Mycoplasma Idioma: En Ano de publicação: 2020 Tipo de documento: Article