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Stability Evaluation of Hydrogen Peroxide Uptake Samples from Monoclonal Antibody Drug Product Aseptically Filled in Vapor Phase Hydrogen Peroxide-Sanitized Barrier Systems: A Case Study.
Eisner, Devon Roshan; Hui, Ada; Eppler, Kirk; Tegoulia, Vassia; Maa, Yuh-Fun.
Afiliação
  • Eisner DR; Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and.
  • Hui A; Late Stage Pharmaceutical Development, Genentech, a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080.
  • Eppler K; Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and.
  • Tegoulia V; Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and.
  • Maa YF; Pharmaceutical Processing and Technology Development, Genentech, a Member of the Roche Group, 1 DNA Way South San Francisco, CA 94080; and maay@gene.com.
PDA J Pharm Sci Technol ; 73(3): 285-291, 2019.
Article em En | MEDLINE | ID: mdl-30651338

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Esterilização / Composição de Medicamentos / Armazenamento de Medicamentos / Congelamento / Peróxido de Hidrogênio / Anticorpos Monoclonais Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Esterilização / Composição de Medicamentos / Armazenamento de Medicamentos / Congelamento / Peróxido de Hidrogênio / Anticorpos Monoclonais Idioma: En Ano de publicação: 2019 Tipo de documento: Article