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.

分层药物定义为针对疾病的药物，在这些疾病中，已根据患者对诊断测试的反应预选了患者进行治疗。这些药物的生产线涵盖了广泛的不同治疗类型，包括细胞和基因疗法，基于肽或蛋白质的疫苗；以及 以及基于蛋白质的疗法。如果要实现负担得起的药物的生产和供应，这些越来越多样化的产品（从定义上讲是市场规模较小的产品）要求在过程设计中提高敏捷性和生产率。在本文中，我们回顾了无细胞合成（CFS）的现状，正在开发的新技术和策略及其在分层药物生产中的应用；专注于蛋白质治疗产品的生产。