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Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine
journal contribution
posted on 2017-08-21, 09:13 authored by Elizabeth RatcliffeElizabeth Ratcliffe, Rob ThomasRob Thomas, David WilliamsBACKGROUND. 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.
Funding
This work was supported by the UK Engineering and Physical Sciences Research Council-funded Centre for Innovative Manufacturing in Regenerative Medicine, which is a partnership of Loughborough, Nottingham and Keele Universities, and industry and the public sector stakeholders.
History
School
- Aeronautical, Automotive, Chemical and Materials Engineering
Department
- Chemical Engineering
Published in
British Medical BulletinVolume
100Issue
1Pages
137 - 155Citation
RATCLIFFE, E., THOMAS, R. and WILLIAMS, D., 2011. Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine. British Medical Bulletin, 100 (1), pp.137-155.Publisher
Oxford University Press (© the author)Version
- VoR (Version of Record)
Publisher statement
This work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/Publication date
2011ISSN
0007-1420eISSN
1471-8391Publisher version
Language
- en