Journal of Innovative Optical Health Sciences, Volume. 14, Issue 3, 2150007(2021)

Determination of the immunoglobulin G precipitation end-point by an intelligent near-infrared spectroscopy system

Chen Yu1, Shuang Quan1, Cui Yang1, Chengliang Zhang2, Jiajin Fan3, Lian Li1,4、*, and Hengchang Zang1,4,5
Author Affiliations
  • 1School of Pharmaceutical Sciences Cheeloo College of Medicine, Shandong University Jinan, Shandong 250012, P. R. China
  • 2University of Jinan, Jinan Shandong 250012, P. R. China
  • 3China Biologic Products Holdings, Inc. Taian, Shandong 271000, P. R. China
  • 4Key Laboratory of Chemical Biology (Ministry of Education) Shandong University Jinan, Shandong 250012, P. R. China
  • 5National Glycoengineering Research Center Shandong University Jinan, Shandong 250012, P. R. China
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    Precipitation is a key manufacturing unit during the immunoglobulin G (IgG) production, which guarantees the quality of the final product. Ethanol is usually used to purify IgG during the precipitation process, so it is important to monitor the ethanol concentration online. Nearinfrared (NIR) spectroscopy is a powerful process analytical technology (PAT) which has been proved to be feasible to determine the ethanol concentration during the precipitation process. However, the NIR model is usually established based on the specific process, so a universal model is needed. And the clarity degree of solution will affect the quality of the spectra. Therefore, in this study an integrated NIR system was introduced to establish a universal NIR model which could predict the ethanol concentration online and determine the end-point of the whole process. First, a spectra acquisition device was designed and established in order to get high-quality NIR spectra. Then, a simple prepared ethanol NIR model was constructed to predict the actual manufacturing process. Finally, the end-point was determined to stop the peristaltic pump when the ethanol concentration reached 20%. The results showed that the spectra quality was good, model prediction was accurate, and process monitoring was accurate. In conclusion, all results indicated that the integrated NIR system could be used to monitor the biopharmaceutical process to help us understand the pharmaceutical process.

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    Chen Yu, Shuang Quan, Cui Yang, Chengliang Zhang, Jiajin Fan, Lian Li, Hengchang Zang. Determination of the immunoglobulin G precipitation end-point by an intelligent near-infrared spectroscopy system[J]. Journal of Innovative Optical Health Sciences, 2021, 14(3): 2150007

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    Paper Information

    Received: Nov. 23, 2020

    Accepted: Dec. 28, 2020

    Published Online: Aug. 6, 2021

    The Author Email: Li Lian (lilian@sdu.edu.cn)

    DOI:10.1142/s1793545821500073

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