Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine

BACKGROUND. A novel manufacturing industry is emerging to translate unique cellular therapy bioprocesses to robust, scaled manufacturing production for successful clinical translation. SOURCE OF DATA. This review summarizes key translational issues, and current and future perspectives to improve translation of cell-based therapy bioprocessing, based on literature search and author research. AREAS OF AGREEMENT. It is widely recognized that cell-based therapies could revolutionize health care for a range of diseases, and that there are gaps in the overarching framework and technologies to generate clinical success. AREAS OF CONTROVERSY. There is limited understanding of how to fulfil requirements as regulatory and manufacturing guidelines are incomplete and few have achieved commercialization. GROWING POINTS. Recent developments are encouraging adoption of automation and quality engineering approaches for bioprocessing of cell-based therapies. AREAS TIMELY FOR DEVELOPING RESEARCH. Include technology development to improve the cost and purity of manufacture and final product quality.