Real-Time Monitoring of Quality Attributes by In-Line Fourier Transform Infrared Spectroscopic Sensors at Ultrafiltration and Diafiltration of Bioprocess

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 at ultrafiltration and diafiltration (UF/DF) unit operation of biologics manufacturing. Learn More