期刊
BRITISH MEDICAL BULLETIN
卷 100, 期 1, 页码 137-155出版社
OXFORD UNIV PRESS
DOI: 10.1093/bmb/ldr037
关键词
cell-based therapy; regenerative medicine; bioprocessing; manufacture; quality engineering; cell culture automation
资金
- UK Engineering and Physical Sciences Research Council
- Engineering and Physical Sciences Research Council [EP/H028277/1] Funding Source: researchfish
- EPSRC [EP/H028277/1] Funding Source: UKRI
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.
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