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

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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.