Smart and flexible end-to-end cGMP mRNA manufacture on demand

RNA疗法将改变许多疾病的治疗标准，从罕见疾病过渡到慢性疾病，并为数百万患者实现个性化医疗。RNA的生成、纯化和递送方面的进步意味着药物可以具有成本效益并靶向新的途径。作为一种颠覆性的治疗技术，小型研究小组和生物技术可以快速开发新的RNA结构。多种rna治疗方式对柔性制造的需求将会增加，以加速其到达患者的路线并提高其经济性。然而，现有的全球RNA制造利用生物制剂并没有优化到RNA的生化制造。柔性制造必须适应不同的产量、过程控制策略、加速交货时间和安全的供应链，同时提高产量、经济性和可持续性。这是一个雄心勃勃的项目，来自两家开拓性的英国中小企业。BiologIC已经开发了基于ivt的mRNA小批量生产（InnovateUK10025959）和cgmp就绪环境下的连续抗体生产（InnovateUK93825）。DeepMirror使用人工智能和专有数据集来寻找具有最佳治疗价值的RNA序列。该项目的数字化方面将由Nvidia提供支持。该系统将提高生产率，增加全长RNA的产量，并利用过程集约化来减少足迹，提高可持续性。该系统将通过灵活的RNA制造进入400亿美元的全球市场，改善患者的生活，并使英国成为使用数字化技术制造RNA的全球领导者。

RNA therapeutics will change the standard of care for many diseases, transitioning from rare to chronic diseases, and actualize personalized medicine for millions of patients.Advances in generating, purifying and delivery of RNA mean drugs can be cost-effective and target new pathways. As a disruptive therapeutic technology, small research groups and biotechs can rapidly develop new RNA constructs.Demand for flexible manufacturing will increase across multiple RNA-therapy modalities to accelerate their route-to-patient and improve their economics. However, existing global RNA manufacturing leveraged from biologics is not optimised to the biochemical manufacturing of RNA.Flexible manufacturing must accommodate different production volumes, process control strategies, accelerated lead times and secure supply chains, while improving yields, economics and sustainability.This is an ambitious project from two pioneering UK SMEs. BiologIC has developed IVT-based small-batch manufacturing of mRNA (InnovateUK10025959) and continuous antibody manufacturing in a cGMP-ready environment (InnovateUK93825). DeepMirror uses AI and proprietary datasets to find RNA sequences optimised for therapeutic value. Digitilisation aspects of the project will be supported by Nvidia.The system will improve productivity, increase yields of full-length RNA and use process intensification to reduce footprint, improving sustainability.The system will access the $40bn global market through flexible RNA manufacturing, improve patient lives and establish the UK as a global leader in the manufacture of RNA using digitilisation technologies.