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Validation and optimization of viral clearance in a downstream continuous chromatography setting.
Chiang, Meng-Jung; Pagkaliwangan, Mark; Lute, Scott; Bolton, Glen; Brorson, Kurt; Schofield, Mark.
Afiliación
  • Chiang MJ; Division of Biotechnology Review and Research II, Office of Biotechnology Products, Office of Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pagkaliwangan M; Biotechnology Process Research and Development, Pall Biotech, Westborough, Massachusetts.
  • Lute S; Division of Biotechnology Review and Research II, Office of Biotechnology Products, Office of Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bolton G; Amgen, Cambridge, Massachusetts.
  • Brorson K; Regulatory Consulting Services, Parexel International, Bethesda, Maryland.
  • Schofield M; Biotechnology Process Research and Development, Pall Biotech, Westborough, Massachusetts.
Biotechnol Bioeng ; 116(9): 2292-2302, 2019 09.
Article en En | MEDLINE | ID: mdl-31112283

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Virus / Modelos Químicos / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: Biotechnol Bioeng Año: 2019 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Virus / Modelos Químicos / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: Biotechnol Bioeng Año: 2019 Tipo del documento: Article