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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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Frontiers of Chemical Science and Engineering 2015年第3期9卷 386-406页

作者： Huiquan Wu Erik Read Maury White Brittany Chavez Kurt Brorson Cyrus Agarabi Mansoor Khan 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

Compared to small molecule process analytical technology （PAT） applications, biotechnology product PAT applications have certain unique challenges and opportunities. Understanding process dynamics of bioreactor cell culture process is essential to establish an appropriate process control strategy for biotechnology product PAT applications. Inline spectroscopic techniques for real time monitoring of bioreactor cell culture process have the distinct potential to develop PAT approaches in manufac- turing biotechnology drug products. However, the use of inline Fourier transform infrared （FTIR） spectroscopic techniques for bioreactor cell culture process monitoring has not been reported. In this work, real time inline FTIR Spectroscopy was applied to a lab scale bioreactor mAb IgG3 cell culture fluid biomolecular dynamic model. The technical feasibility of using FTIR Spectroscopy for real time tracking and monitoring four key cell culture metabolites （including glucose, glutamine, lactate, and ammonia） and protein yield at increasing levels of complexity （simple binary system, fully formulated media, actual bioreactor cell culture process） was evaluated via a stepwise approach. The FTIR fingerprints of the key metabolites were identified. The multivariate partial least squares （PLS） calibration models were established to correlate the process FTIR spectra with the concentrations of key metabolites and protein yield of in-process samples, either individually for each metabolite and protein or globally for all four metabolites simultaneously. Applying the 2＇ld derivative pre-processing algorithm to the FTIR spectra helps to reduce the number of PLS latent variables needed significantly and thus simplify the interpretation of the PLS models. The validated PLS models show promise in predicting the concentration profiles of glucose, glutamine, lactate, and ammonia and protein yield over the course of the bioreactor cell culture process. Therefore, this work demonstrated the t

关键词： process analytical technology (PAT) Fouriertransform infrared (FTIR) spectroscopy partial least squares (PLS) regression mouse IgG3 bioreactor cell culture process real time process monitoring

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