Novel Platform Technology for Scaled Down Process Development and Optimisation of Regenerative Medicines

The project aim is for TAP Biosystems, The Cell Therapy Catapult and University College London to develop a small scale benchtop bioreactor that can be applied to cell therapy appliations, to test and validate the performance of the new bioreactor system with exemplar cell line expansion processes representative of both allogeneic and autologous therapies, and to gather input from regultory agencies on the appropriate levels of validation required for the system to be adopted into GMP facilities. An extensive commerical and market research activity will ensure the biorector has the appropriate user requirement specifications for both allogenic and autologous cell therapy applications that can advance the development and commercialisation of cell therapies by providing a tool for scaled down process optimisation and small scale production are affordable, well characterised and scaleable. Achieving this will reduce cell therapy development cost and time and acclerate delivery novel cell therapies to patients.