Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine.
Ratcliffe, Elizabeth; Thomas, Robert J.; Williams, David J.
[Article]
British Medical Bulletin.
100(1):137-155, December 2011.
(Format: HTML, PDF)
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.
(C) British Council 2011. Published by Oxford University Press. All rights reserved.