渗滤
过程分析技术
超滤(肾)
工艺工程
生物过程
偏最小二乘回归
可视化
计算机科学
傅里叶变换
过程(计算)
生物系统
数据挖掘
化学
工程类
色谱法
机器学习
数学
膜
微滤
生物化学
生物
化学工程
操作系统
数学分析
作者
Dhanuka P. Wasalathanthri,Hasin Feroz,Neha Puri,Jessica Hung,Gregory C. Lane,Melissa Holstein,Letha Chemmalil,Douglas Both,Sanchayita Ghose,Julia Ding,Zheng Jian Li
摘要
Abstract Technologies capable of monitoring product quality attributes and process parameters in real time are becoming popular due to the endorsement of regulatory agencies and also to support the agile development of biotherapeutic pipelines. The utility of vibrational spectroscopic techniques such as Fourier transform mid‐infrared (Mid‐IR) and multivariate data analysis (MVDA) models allows the prediction of multiple critical attributes simultaneously in real time. This study reports the use of Mid‐IR and MVDA model sensors for monitoring of multiple attributes (excipients and protein concentrations) in real time (measurement frequency of every 40 s) at ultrafiltration and diafiltration (UF/DF) unit operation of biologics manufacturing. The platform features integration of fiber optic Mid‐IR probe sensors to UF/DF set up at the bulk solution and through a flow cell at the retentate line followed by automated Mid‐IR data piping into a process monitoring software platform with pre‐loaded partial least square regression (PLS) chemometric models. Data visualization infrastructure is also built‐in to the platform so that upon automated PLS prediction of excipients and protein concentrations, the results were projected in a graphical or numerical format in real time. The Mid‐IR predicted concentrations of excipients and protein show excellent correlation with the offline measurements by traditional analytical methods. Absolute percent difference values between Mid‐IR predicted results and offline reference assay results were ≤5% across all the excipients and the protein of interest; which shows a great promise as a reliable process analytical technology tool.
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