Translation of Step-changing Bioprocesses and Expression System Technologies for Next Generation Protein Biologics Production in CHO Cells

中国仓鼠卵巢(CHO)细胞是每年1450亿美元蛋白质生物制剂的主要生产主体，这些蛋白质生物制剂被用作治疗一系列疾病的药物。在考虑生产单抗时，CHO平台是成熟的，但新形式的非天然分子，如融合蛋白、抗体片段和其他外来分子，仍然难以在这个或任何其他宿主中表达(DTE)。该项目建立在概念验证工作的基础上，该工作表明，设计CHO底盘以及生长介质操作，可以提高一些DTE蛋白质的产量和质量，这些蛋白质正在开发中，用于未得到满足的临床需求和目前没有治疗方法的疾病。该项目将把我们的初步发现的技术准备水平提高到概念验证之外，以实现用于DTE蛋白质的新CHO细胞系统的商业化以及相关的生物工艺，为生产这些重要的新药做好准备。

Chinese hamster ovary (CHO) cells are the main production host for >US$145billion/yr of protein biologics used as medicines for a range of diseases. The CHO platform is mature when considering production of monoclonal antibodies, but new format non-native molecules such as fusion proteins, antibody fragments and other exotic molecules remain difficult to express (DTE) in this, or any other host. This project builds upon proof of concept work demonstrating that engineering the CHO chassis, together with growth media manipulation, increases both the yield and quality of a number of DTE proteins that are in development for application to unmet clinical needs and diseases with no current treatments. The project will advance the technology readiness level of our preliminary findings beyond proof-of-concept to deliver the commercialization of new CHO cell systems for DTE proteins and associated bioprocesses ready for industrial application to produce these important new medicines.