Developments in Insulin Manufacturing Using Cell-Free Systems

Authors: 
Borhani, S. - Presenter, University of Maryland Baltimore County
Gurramkonda, C., University of Maryland Baltimore County
Frey, D., University of Maryland Baltimore County
Tolosa, L., University of Maryland Baltimore County
Swartz, J., Stanford University
Rao, G., University of Maryland Baltimore County
According to a 2014 study by the WHO, 422 million people were diabetic globally, with low to middle income communities being most effected. Currently, half of the global diabetic population lacks reliable insulin access. This increase in prevalence and supply limitation motivates changes in the current manufacturing paradigm toward developing new devices that make insulin more accessible. We aim to develop a manufacturing technology that allows for rapid insulin production at the point-of-care. In doing so, we utilize a variety of different cell-free platforms to express proinsulin and pre-proinsulin. The expressed product is then immobilized on a chromatography column where an “on-column” conversion process removes the C-peptide and signal sequence. This approach allows for more efficient production of insulin, while also reducing the burden on downstream purification steps. Additionally, when this approach is coupled with innovative process analytical technology, rapid evaluation of the final product could enable real-time release.