AUTOSTEM · Development of closed, scalable and AUTOmated robotic systems for therapeutic STEM cell manufacturing: aseptic systems from “Donor-to-Patient”

AUTOSTEM will develop closed, scaleable and automated systems for therapeutic cell manufacture. The project vision is a donor-to-patient system where all aspects of processing, from tissue harvest to patient delivery are fully closed and aseptic. The process will involve new methods of biological cell selection from marrow, fat or other tissues, bioreactors to achieve scale and media formulations that are fully xeno-free. Process monitoring will utilise remote sensing and the automated retrieval of cells for microscopy, flow cytometry, karyotyping, differentiation or other tests. The final product will be a cryobag containing a specified cell dose, ready for thawing and clinical delivery.AUTOSTEM will be the factory of the future for therapeutic cell manufacturing. This system could ultimately be scaled for hospital-based use to produce autologous cells or at industrial scale for allogeneic therapy. It will achieve consistent cell production, minimise contamination, maximise scale and reduce cost of goods, thus enabling routine clinical use of cell therapies.The consortium will be a partnership of academic centres and industry with expertise across the disciplines relevant to the research and development goals. It will also include expertise in GMP and regulatory compliance and in healthcare economic analysis.