In recent years, the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have stressed the need of greater process understanding and control in the area of pharmaceutical development, manufacturing and quality assurance, all which is summarized in the Process Analytical Technology (PAT) initiative. Therefore, in bioprocesses, and particularly in cell cultures, multivariate data acquisition and analysis are likely to provide versatile and significant real-time information. Lately, Raman spectroscopy has been characterized as a promising tool to detect multiple process variables simultaneously.
This work presents several cases studies, where Raman spectroscopy was successfully applied for the quantification of significant variables in monoclonal antibody (mAb) cell culture processes. These studies include online monitoring of fed-batch cultures, offline analysis of (partially spiked) cell culture samples as well as the utilization in perfusion cell culture processes. Besides the evaluation of those applications of Raman spectroscopy, the central role of multivariate spectra processing techniques including pretreatment, spectral range selection and data reduction will be discussed with regards to robust calibration and prediction of the components of interest. Finally, the role of those spectral data with regards to overall process prediction, monitoring and control will be highlighted within the scope of all acquired online and offline data in bioprocesses.
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum