Raman Process Modelling and Glucose Control for Biologies

摘要

Pharmaceutical manufacturing continues to expand the use of Raman spectroscopy and is especially useful in CHO cell-based processes such as mAb production. By developing models, Raman can be used to measure and control various aspects of upstream and downstream biological manufacturing. The upstream Raman models have demonstrated the capability to measure critical cell culture attributes and metabolic concentrations, however the accuracy of these measurements can vary.1 The prediction accuracy has been shown to improve by increasing the sampling frequency and adopting machine learning models which resulted in the ability to control metabolic concentrations within cell culture when enabled with closed loop control. Recent cell culture studies have accomplished glucose control within a ± 0.5 g/L range of the targeted concentration over the course of a multi-day process. The ability to successfully monitor and control glucose and other critical cell culture metabolites has provided insights and capabilities to increase titer production and provide more consistent product quality data while also greatly advancing the effectiveness of troubleshooting.