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

Autor: Chen Yu, Shuang Quan, Cui Yang, Chengliang Zhang, Jiajin Fan, Lian Li, Hengchang Zang
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of Innovative Optical Health Sciences, Vol 14, Iss 3, Pp 2150007-1-2150007-7 (2021)
Druh dokumentu: article
ISSN: 1793-5458
1793-7205
17935458
DOI: 10.1142/S1793545821500073
Popis: 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. Near-infrared (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.
Databáze: Directory of Open Access Journals
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