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Philos Trans A Math Phys Eng Sci. 2012 Aug 28;370(1973):3924-49. doi: 10.1098/rsta.2011.0049.

Precision manufacturing for clinical-quality regenerative medicines.

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1
Healthcare Engineering Group, Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough LE11 3TU, UK. d.j.williams2@lboro.ac.uk

Abstract

Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice-extreme levels of repeatability and reliability-demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.

PMID:
22802496
DOI:
10.1098/rsta.2011.0049
[Indexed for MEDLINE]
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