Precision manufacturing for clinical-quality regenerative medicines
journal contributionposted on 24.06.2014 by David Williams, Rob Thomas, Paul Hourd, Amit Chandra, Elizabeth Ratcliffe, Yang Liu, Erin Rayment, J. Richard Archer
Any type of content formally published in an academic journal, usually following a peer-review process.
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.
- Mechanical, Electrical and Manufacturing Engineering