Scale up of optical fractionation for bio-processing

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Human pluripotent stem cells are the primary template cells for nearly all the cell types within the body. The exclusivity of these cells arises from their unmatched capability to remain in an unspecialised state until they are induced to differentiate (change from being a stem cell to a cell that has a specific function in the organism). A major challenge of regenerative medicine is to exploit these twin properties to provide wide-ranging novel therapies through the manufacture of beneficial cell types at scale. To date, one of the principal bottlenecks in the development of large scale cell therapies has been the lack of manufacturing-suitable cell separation and purification technologies, effectively limiting the production of products pure enough for wide scale human trials.This bottleneck is caused by the need for safety and efficacy in sorting cells to high purity without adding antibodies or other modifying agents, in order to remove residual pluripotent cells and also for the identification and definition of the cells in the final product. Hence what regenerative medicine needs in order to be translated into a manufacturing process is a scalable label-free sorting technology. This implies passive sorting which can both be done without labelling and in a highly parallelised manner. However, passive cell sorting technologies require a pathfinder application to fully demonstrate its critical importance to the progression of cell therapy commercialisation. We intend to fulfil this key step by developing scalable passive optical sorting technologies for large scale red blood cell (RBC) manufacture.The UK has a particularly strong research base in regenerative medicine, yet the opportunities for protecting IP in the development of due to an EU Court of Justice ruling which means that cells derived from human embryonic stem cells (hESCs) cannot be patented. This means that the IP supporting any translation of regenerative medicine involving hESCs will come from the process by which cells are derived (which is still open to patenting). As a result the value of the process is increased, including IP based on manufacturing. Hence, cell sorting techniques developed for regenerative medicine will form the backbone of value creation in hESC derived cell therapies and will be an important mechanism for keeping UK (and European) research competitive with US and Asian competitors.