(367a) Process Analytical Utility of Raman Microspectroscopy for Monitoring Cellular Therapy Manufacturing

A major wave of promising cellular therapies is progressing through clinical trials, with the potential to one day improve treatments for cancer, diabetes, cardiac and other degenerative diseases. Given the complexity of mammalian cells, the success of these therapies will to a great extent depend on developing robust methods to reliably monitor both the production processes and assess the quality of the manufactured cell products. Raman spectroscopy offers a non-invasive and label-free approach to distinguish different cell types and physiological states by analyzing macromolecular composition changes in living cells. Spectral markers, such as the ratio of nucleic acid to protein-associated band intensities, have been used to discriminate between stem cells and their differentiated progeny. Both the types of cell death and apoptotic stages can be distinguished. Thus, Raman spectral indicators have a great potential to provide a highly informative, non-destructive means to monitor cellular changes in manufacturing processes for cell-based therapy products.