Novel production process for a highly potent recombinant protein using doggybone DNA (dbDNA) vector and cell free expression technology

有毒药物正在成为制药行业的主要焦点，因为高效力产品需要最小量的剂量给患者，因此材料要求很低。然而，与这些有毒产品一起工作的相关风险可能会使其发展成为问题，传统的制造路线往往不适合。本项目将研究使用无细胞表达从“狗骨DNA”（dbDNA）载体生产肉毒杆菌毒素。该项目将开发一个用于生产dbDNA的闭环系统，并筛选各种条件以优化无细胞表达系统，用于毒素的封闭处理，以消除与高效生物制药生产相关的健康和安全风险以及技术产量限制。该项目由Ipsen Biopharm领导，涉及Touchlight Genetics和工艺创新中心。

Toxic medicines are becoming a major focus of the pharmaceutical industry, as high potency products need minimal amounts to dose patients and so material requirements are low. However, the associated risks of working with these toxic products can make their development problematic, and traditional manufacturing routes are often unsuitable. This project will examine using cell free expression to produce a botulinum toxin from a "doggybone DNA" (dbDNA) vector. The project will develop a closed loop system for producing dbDNA, and screen a wide range of conditions to optimise a cell free expression system, for enclosed processing of toxins to negate the health and safety risks and technical yield limitations associated with high potency biopharmaceutical production. The project is a collaboration led by Ipsen Biopharm, involving Touchlight Genetics and the Centre for Process Innovation.