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.