Online Protein Content Monitoring And Quantitative Model Transfer In The Process Of Plasma Ethanol Precipitation By Near Infrared Spectroscopy

In most production process of blood products,cold ethanol precipitation is one of the important separation and purification methods for the separation and purification of blood products.Plasma precipitation plays an important key role in the production of blood products.Because of the particularity of raw material plasma,it is difficult to ensure repeatability and consistency among batches.Therefore,process analysis technology(PAT)is introduced into the process of plasma alcohol precipitation.And alcohol precipitation process is optimized through process monitoring and content prediction to improvie plasma utilization.Near infrared spectroscopy(NIRs)technology is a fast,non-destructive,and green process monitoring method.It can achieve on-line monitoring and content prediction in the process of plasma ethanol precipitation.In the process of using NIRS,when establishing NIRS models,we often need to measure the chemical or basic properties of a large number of samples as data basis,with large investment and high cost.Antaris II is large in bulk and high in resolution.It is suitable for laboratory determination;Micro NIR 1700 is small and low resolution.It is suitable for handheld measurement.If the resolution can be improved and the price of the instrument can be reduced,it will be of great significance to the popularization and application of near infrared technology.Therefore,the research is innovated in near infrared model transfer among two different types of NIR spectrometer which has important guiding significance and reference value for fast and nondestructive testing of production and products.In this study,NIRS was applied to the process of plasma alcohol precipitation.Process monitoring and content determination for the upstream part of the key blood products were carried out.And Antaris II and Micro NIR 1700 models with different wavelengths were transferred.The main contents of this paper are as follows:(1)Research on the on-line quality control of in the process of plasma alcohol precipitation by using NIRsIn this study,the plasma alcohol precipitation process was used as the research system.Five batches of normal production processes and 3 batches of abnormal production were simulated in the laboratory.And the monitoring ability of NIRs to the plasma alcohol precipitation process was discussed.Based on the matheds of original spectrum trend analysis,principal component analysis(PCA),multivariate statistical process control(MSPC)and protein content analysis shows that NIRs can realize the process monitoring of the plasma and alcohol precipitation.And the NIRs are more accurate compared with the protein content offline monitoring method.From the analysis of the MSPC results,it is known that the main component score and the Hotelling T2 can be used to monitor the abnormal conditions.(2)Research on the monitoring protein content in the process of alcohol precipitation by using NIRsIn this study,a total of 12 batches of plasma alcohols were simulated in the laboratory and the corresponding infrared spectra were collected.After the sample set derivation,spectral pretreatment and variable selection,the best model was established of quantitative analysis of total protein,human albumin and globulin in the process of plasma ethanol precipitation.And determination coefficient of calibration(Rc2),determination coefficient of validation(Rp),root mean square error of calibration(RMSEC),root mean square error of prediction(RMSEP)were 0.6418g/L,0.8469g/L,0.9895 and 0.9802 for tatal protein;0.6752g/L,1.042g/L,0.9560 and 0.9490 for HA;and 1.248g/L,1.268g/L,Rc2 0.9482 and R,2 0.9422 for IgG.(3)Research on model transfer in the process of alcohol precipitation by using NIRsIn this study,8 batches of plasma alcohol precipitation processes were simulated,and the corresponding spectra were collected by Antaris II and Micro NIR 1700,respectively.And the Partial Least Squares Regression(PLSR)models were established respectively.After comparing the modeling results of Antaris ?,Micro NIR 1700 and model transfer,it is found that the accuracy of Micro NIR 1700 model is increased after the model transfer by total protein,HA and IgG.The innovative points are listed as below:(1)This research brought piecewise reverse standardization(PRS)model transfer algorithm to the determinate of total protein,HA and IgG during plasma alcohol precipitation process.(2)This paper investigated the quantitive and qualitative model of toatal protein,HA and IgG on plasma alcohol precipitation by using NIRs...