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.