正文
《化学科学与工程前沿(英文)》 >> 2015年 第9卷 第3期 doi: 10.1007/s11705-015-1533-3
Real time monitoring of bioreactor mAb IgG3 cell culture process dynamics via Fourier transform infrared spectroscopy: Implications for enabling cell culture process analytical technology? ?
1. 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. 2. 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. 3. 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
摘要
关键词
process analytical technology (PAT) ; Fourier-transform infrared (FTIR) spectroscopy ; partial least squares (PLS) regression ; mouse IgG3 ; bioreactor cell culture process ; real time process monitoring
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