2134/14993
David Williams
David
Williams
Rob Thomas
Rob
Thomas
Paul Hourd
Paul
Hourd
Amit Chandra
Amit
Chandra
Elizabeth Ratcliffe
Elizabeth
Ratcliffe
Yang Liu
Yang
Liu
Erin Rayment
Erin
Rayment
J. Richard Archer
J. Richard
Archer
Precision manufacturing for clinical-quality regenerative medicines
Loughborough University
2014
Regenerative medicine
Stem cells
Manufacturing
Automation
Characterization
Mechanical Engineering not elsewhere classified
2014-06-24 12:08:20
Journal contribution
https://repository.lboro.ac.uk/articles/journal_contribution/Precision_manufacturing_for_clinical-quality_regenerative_medicines/9564482
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.