Feasibility of single use systems for flexible pDNA manufacture and improved service offering

作为临床试验的一部分，细胞和基因治疗产品正在改变接受治疗的患者的生活。质粒DNA是开发和生产病毒载体所需的关键材料，以支持这些创新基因治疗产品的临床试验和市场供应，从而治疗患者。该项目由Cobra Biologics领导，旨在利用最先进的一次性技术和3D打印技术进行小规模可行性研究，以提供在英国大规模质粒DNA制造所需的关键工艺信息。该项目将支持Cobra Biologics加大投资，以提高生产能力，保留英国业务，并为临床和商业生产开发进入新市场的机会。提供增强的制造服务将支持现有和新客户的临床和商业抱负，从而使更多创新的基因治疗药物惠及患者。

Cell and gene therapy products are changing the lives of patients receiving treatment as part of clinical trials. Plasmid DNA represents a critical material required to enable the development and production of viral vectors to support both clinical trials and in-market supply for these innovative Gene Therapy products in order to treat patients. This project, lead by Cobra Biologics, aims to perform small scale feasibility studies utilising state of the art single-use technology and 3D printing to deliver critical process information requried to progress towards large scale plasmid DNA manufacturing in the UK. The project will support a larger investment by Cobra Biologics to enhance production capability, enabling retention of UK buisness and developing opportunities to move into new markets for clinical and commercial manufacture. Delivery of an enhanced manufacturing service offering will support existing and new customers' clinical and commercial ambitions, leading to more innovative Gene Therapy medicines reaching patients.