Bioreactor-based, clinically oriented manufacturing of engineered tissue (BIO-COMET)

Despite the compelling clinical need to regenerate damaged tissues/organs, the impressive advances in the field of tissue engineering have yet to result in viable engineered tissue products with wide-spread therapeutic adoption. Manufacturing-related issues, including regulatory compliance, standardization, up-scaling, and cost-effectiveness, have been proposed as central challenges to be addressed for the commercial success of a cell-based engineered product. In fact, the central bioprocesses for engineering cell-based grafts have traditionally been, and continue to be, based on conventional manual benchtop techniques, which due to the large number of manual and laborintensive manipulations required, possess inherent risks of contamination, potential high intra- and inter-operator variability, limited scale-up opportunity, and high manufacturing costs in the long-term.