Williams, David J. and Thomas, Robert J. and Hourd, Paul C. and Chandra, Amit and Ratcliffe, Elizabeth and Liu, Yang and Rayment, Erin A. and Archer, J. Richard (2012) Precision manufacturing for clinical-quality regenerative medicines. Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences, 370 (1973). pp. 3924-3949. ISSN 1364-503X
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.
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