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

Journal of Innovative Optical Health Sciences

关键词: Near infrared spectroscopy;    human albumin;    acid precipitation process;    pH value;    chemometrics;   

DOI  :  10.1142/S1793545818500098

学科分类：医学（综合）

来源: World Scientific Publishing Co. Pte. Ltd.

【 摘 要 】

Human albumin (HA) is a very important blood product which requires strict quality control strategy. Acid precipitation is a key step which has a great effect on the quality of final product. Therefore, a new method based on quality by design (QbD) was proposed to investigate the feasibility of realizing online quality control with the help of near infrared spectroscopy (NIRS) and chemometrics. The pH value is the critical process parameter (CPP) in acid precipitation process, which is used as the end-point indicator. Six batches, a total of 74 samples of acid precipitation process, were simulated in our lab. Four batches were selected randomly as calibration set and remaining two batches as validation set. Then, the analysis based on material information and three different variable selection methods, including interval partial least squares regression (iPLS), competitive adaptive reweighted sampling (CARS) and correlation coefficient (CC) were compared for eliminating irrelevant variables. Finally, iPLS...

【 授权许可】

Unknown