Cell free protein synthesis: a viable option for stratified medicines manufacturing?

Stratified medicines are defined as medicines which target diseases where the patients have been preselected for treatment based on their response to a diagnostic test. The pipeline of these medicines cover a wide range of different treatment types including cell and gene therapies, vaccines based on peptides or proteins; and protein based therapies. These increasingly diverse and by definition smaller market size products require improved agility and productivity in process design if manufacture and supply of affordable medicines is to be achieved. In this paper we review the current state of cell free synthesis (CFS), the new technologies and strategies being developed and its application to the production of stratified medicines; focusing on the production of protein based therapeutic products.