10088776Accelerating the manufacture of RNA therapiesClosedCollaborative R&DInnovate UKRNA therapeutics will change the standard of care for many diseases, transitioning from rare to chronic diseases, and actualize personalized medicine for millions of patients. Demand for flexible cGMP manufacturing will significantly increase across multiple RNA-therapy modalities to accelerate their route-to-patient and improve their economics. However, existing global RNA manufacturing leveraged from biologics, built rapidly during COVID19, is not optimised to the biochemical manufacturing of RNA. Therapies are manufactured in classical centralised batches with poor scalability, high costs and complex supply chains. New manufacturing options can now build upon this infrastructure to support scale-out of new RNA therapies from R&D to cGMP and accommodate a wide range of RNA production volumes, advanced process control strategies, accelerated lead times and secure supply chains, while improving yields, economics and sustainability. This is an ambitious collaboration from pioneering UK SMEs BiologIC Technologies and Epitopea. BiologIC is the inventor of the biocomputer, a new category of machine built from fluidic chips designed like computer chips. Epitopea is a global leader in exploiting a novel class of untapped tumour-specific antigens designed to treat a broad patient population. BiologIC will apply its biocomputer system to the delivery of a true platform process enabling rapid-response manufacturing of a broad range of RNA therapies, demonstrated with Epitopea's RNA therapy workflow. BiologIC Technologies brings disruptive industry 4.0 technology that enables distributed end-to-end biomanufacturing. The objective is to build a medical technology for rapid, economically accessible, environmentally sustainable, globally distributed, end-to-end RNA therapy manufacture on demand. BiologIC has already developed IVT-based small-batch mRNA manufacturing (InnovateUK10025959) and continuous antibody manufacturing in a cGMP-ready environment (InnovateUK93825). Epitopea has a number of RNA therapy candidates in pre-clinical development. The system will substantially reduce RNA therapy costs and distribute flexible manufacturing to any point of need in the rapidly evolving supply chain. The system will improve productivity, increase yields of full-length RNA and use process intensification to reduce footprint, improving sustainability. 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.