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An ICP-MS platform for metal content assessment of cell culture media and evaluation of spikes in metal concentration on the quality of an IgG3:κ monoclonal antibody during production.
Mohammad, Adil; Agarabi, Cyrus; Rogstad, Sarah; DiCioccio, Elizabeth; Brorson, Kurt; Ashraf, Muhammad; Faustino, Patrick J; Madhavarao, Chikkathur N.
Afiliação
  • Mohammad A; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Agarabi C; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Rogstad S; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • DiCioccio E; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Brorson K; Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Ashraf M; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Faustino PJ; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States.
  • Madhavarao CN; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD, 20993, United States. Electronic address: Chikkathur.Madhavarao@fda.hhs.gov.
J Pharm Biomed Anal ; 162: 91-100, 2019 Jan 05.
Article em En | MEDLINE | ID: mdl-30227357
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Espectrometria de Massas / Imunoglobulina G / Cadeias kappa de Imunoglobulina / Cobre / Meios de Cultura / Glucuronidase / Ferro / Anticorpos Monoclonais Idioma: En Ano de publicação: 2019 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Espectrometria de Massas / Imunoglobulina G / Cadeias kappa de Imunoglobulina / Cobre / Meios de Cultura / Glucuronidase / Ferro / Anticorpos Monoclonais Idioma: En Ano de publicação: 2019 Tipo de documento: Article