Precision manufacturing for clinical-quality regenerative medicines

Article

Williams, David J., Thomas, Robert J., Hourd, Paul C., Chandra, Amit, Ratcliffe, Elizabeth, Liu, Yang, 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. https://doi.org/10.1098/rsta.2011.0049
Article Title

Precision manufacturing for clinical-quality regenerative medicines

ERA Journal ID39720
Article CategoryArticle
AuthorsWilliams, David J. (Author), Thomas, Robert J. (Author), Hourd, Paul C. (Author), Chandra, Amit (Author), Ratcliffe, Elizabeth (Author), Liu, Yang (Author), Rayment, Erin A. (Author) and Archer, J. Richard (Author)
Journal TitlePhilosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences
Journal Citation370 (1973), pp. 3924-3949
Number of Pages26
Year2012
Place of PublicationLondon, United Kingdom
ISSN1364-503X
1471-2962
Digital Object Identifier (DOI)https://doi.org/10.1098/rsta.2011.0049
Web Address (URL)http://rsta.royalsocietypublishing.org/content/370/1973/3924
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.

Keywordsautomation; characterization; manufacturing; regenerative medicine; stem cells
ANZSRC Field of Research 2020401412. Precision engineering
320606. Regenerative medicine (incl. stem cells)
350715. Quality management
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Byline AffiliationsLoughborough University, United Kingdom
Institution of OriginUniversity of Southern Queensland
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