Precision manufacturing for clinical-quality regenerative medicines

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


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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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: © 2012 The Royal Society. Permanent restricted access to published version due to publisher copyright policy.
Faculty/School / Institute/Centre: No Faculty
Faculty/School / Institute/Centre: No Faculty
Date Deposited: 05 Nov 2014 04:30
Last Modified: 06 Feb 2017 03:40
Uncontrolled Keywords: automation; characterization; manufacturing; regenerative medicine; stem cells
Fields of Research (2008): 09 Engineering > 0910 Manufacturing Engineering > 091011 Precision Engineering
10 Technology > 1004 Medical Biotechnology > 100404 Regenerative Medicine (incl. Stem Cells and Tissue Engineering)
15 Commerce, Management, Tourism and Services > 1503 Business and Management > 150313 Quality Management
Fields of Research (2020): 40 ENGINEERING > 4014 Manufacturing engineering > 401412 Precision engineering
32 BIOMEDICAL AND CLINICAL SCIENCES > 3206 Medical biotechnology > 320606 Regenerative medicine (incl. stem cells)
35 COMMERCE, MANAGEMENT, TOURISM AND SERVICES > 3507 Strategy, management and organisational behaviour > 350715 Quality management
Socio-Economic Objectives (2008): B Economic Development > 86 Manufacturing > 8608 Human Pharmaceutical Products > 860899 Human Pharmaceutical Products not elsewhere classified
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