title: Near infrared spectroscopy combined with multivariate analysis for monitoring the ethanol precipitation process of fraction I+II+III supernatant in human albumin separation.
abstract: Nowadays, as a powerful process analytical tool, near infrared spectroscopy (NIRS) has been widely applied in process monitoring. In present work, NIRS combined with multivariate analysis was used to monitor the ethanol precipitation process of fraction I+II+III (FI+II+III) supernatant in human albumin (HA) separation to achieve qualitative and quantitative monitoring at the same time and assure the product's quality. First, a qualitative model was established by using principal component analysis (PCA) with 6 of 8 normal batches samples, and evaluated by the remaining 2 normal batches and 3 abnormal batches. The results showed that the first principal component (PC1) score chart could be successfully used for fault detection and diagnosis. Then, two quantitative models were built with 6 of 8 normal batches to determine the content of the total protein (TP) and HA separately by using partial least squares regression (PLS-R) strategy, and the models were validated by 2 remaining normal batches. The determination coefficient of validation (Rp2), root mean square error of cross validation (RMSECV), root mean square error of prediction (RMSEP) and ratio of performance deviation (RPD) were 0.975, 0.501g/L, 0.465g/L and 5.57 for TP, and 0.969, 0.530g/L, 0.341g/L and 5.47 for HA, respectively. The results showed that the established models could give a rapid and accurate measurement of the content of TP and HA. The results of this study indicated that NIRS is an effective tool and could be successfully used for qualitative and quantitative monitoring the ethanol precipitation process of FI+II+III supernatant simultaneously. This research has significant reference value for assuring the quality and improving the recovery ratio of HA in industrialization scale by using NIRS.
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.
authors.forename: Can
authors.initials: C
authors.lastname: Li
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Wang
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.
authors.forename: Lixuan
authors.initials: L
authors.lastname: Zang
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China. Electronic address: zanghcw@126.com.
authors.forename: Hengchang
authors.initials: H
authors.lastname: Zang
authors.affiliation: Department of Chemistry, Faculty of Sciences, Universitat Autònoma de Barcelona, 08193 Bellaterra, Barcelona, Spain. Electronic address: Manel.Alcala@uab.cat.
authors.forename: Manel
authors.initials: M
authors.lastname: Alcalà
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Nie
authors.affiliation: Shandong Taibang Biological Products Limited Company, No. 14 East Hushan Road, Taian 271000, China.
authors.forename: Mingyu
authors.initials: M
authors.lastname: Wang
authors.affiliation: School of Pharmaceutical Sciences and National Glycoengineering Research Center, Shandong University, Wenhuaxi Road 44, Jinan 250012, China.
authors.forename: Lian
authors.initials: L
authors.lastname: Li
mesh_terms: D002138:Calibration; D011232:Chemical Precipitation; D000431:Ethanol / Q000737:chemistry*; D006801:Humans; D016018:Least-Squares Analysis; D015999:Multivariate Analysis; D025341:Principal Component Analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D000075462:Serum Albumin, Human / Q000302:isolation & purification*; D019265:Spectroscopy, Near-Infrared / Q000379:methods*
chemical_list: D000431:Ethanol; D000075462:Serum Albumin, Human
keywords: Ethanol precipitation process; Human albumin; Near infrared spectroscopy; Qualitative analysis; Quantitative determination