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Br Med Bull. 2011;100:137-55. doi: 10.1093/bmb/ldr037. Epub 2011 Aug 17.

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

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1
Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, LE11 3TU, UK. e.ratcliffe@lboro.ac.uk

Abstract

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.

PMID:
21852279
DOI:
10.1093/bmb/ldr037
[Indexed for MEDLINE]
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