首页> 中文期刊>中国高等学校学术文摘·化学工程 >Real time monitoring of bioreactor mAb IgG3 cell culture process dynamics via Fourier transform infrared spectroscopy: Implications for enabling cell culture process analytical technology

Real time monitoring of bioreactor mAb IgG3 cell culture process dynamics via Fourier transform infrared spectroscopy: Implications for enabling cell culture process analytical technology

     

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  • 来源
    《中国高等学校学术文摘·化学工程》|2015年第3期|386-406|共21页
  • 作者单位

    Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Process Assessment Branch Ⅱ, Division of Process Assessment 1 (DPA 1), Office of Process and Facilities (OPF), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Biotechnology Review and Research Ⅱ (DBRRⅡ), Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Biotechnology Review and Research Ⅱ (DBRRⅡ), Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Biotechnology Review and Research Ⅱ (DBRRⅡ), Office of Biotechnology Products (OBP), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

    Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Federal Research Center at White Oak, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA;

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  • 入库时间 2023-07-26 00:40:16

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