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pH value monitoring during human albumin purification with near infrared spectroscopy and chemometrics

Journal of Innovative Optical Health Sciences 2018年第3期11卷 28-37页

作者： Qiaofeng Sun Zhongyu Sun Fei Wang Lian Li Ronghua Liu Lei Nie Jiayue Wang Mingyu Wang Hengchang Zang School of Pharmaceutical Sciences Shandong University Wenhuaxi Road 44 Jinan 250012P.R.China School of Basic Medical Sciences Shandong University Wenhuaxi Road 44 Jinan 250012P.R.China Shandong Taibang Biological Products Limited Company No.14 East Hushan Road Taian 271000P.R.China

Human albumin(HA)is a very important blood product which requires strict quality *** precipitation is a key step which has a great effect on the quality of final ***,a new method based on quality by design(QbD)was proposed to investigate thefeasibility of realizing online quality control with the help of near infrared spectroscopy(NIRS)and *** pH value is the critical process parameter(CPP)in acid precipitationprocess,which is used as the end-point *** batches,a total of 74 samples of acidprecipitation process,were simulated in our *** batches were selected randomly as cali-bration set and remaining two batches as validation ***,the analysis based on materialinformation and three dfferent variable selection methods,including interval partial least squaresregression(iPLS),competitive adaptive reweighted sampling(CARS)and correlation coeficient(CC)were compared for eliminating irrelevant variables,Fimally,iPLS was used for *** quantitative model was built up by partial least squares regression(PLSR).Thevalues of determination coeficients(R^(2)_(C) and R^(2)_(P)),root mean squares error of prediction(RMSEP),root mean squares error of calibration(RMSEC)and root mean squared error of crossvalidation(RMSECV)were 0.969,0.953,0.0496,0.0695 and 0.0826,*** paired t test and repeatability test showed that the model had good prediction ability and *** results indicated that PLSR model could give accurate measurement of the pH value.

关键词： Near infrared spectroscopy human albumin acid precipition proces pH value chemometrics

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