Precision manufacturing for clinical-quality regenerative medicines | Zendy

David Williams | Zendy; Robert J. Thomas | Zendy; Paul Hourd | Zendy; Amit Chandra | Zendy; Elizabeth Ratcliffe | Zendy; Yang Liu | Zendy; Erin A. Rayment | Zendy; J. Richard Archer | Zendy

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Precision manufacturing for clinical-quality regenerative medicines

Author(s) -

David Williams,

Robert J. Thomas,

Paul Hourd,

Amit Chandra,

Elizabeth Ratcliffe,

Yang Liu,

Erin A. Rayment,

J. Richard Archer

Publication year - 2012

Publication title -

philosophical transactions of the royal society a mathematical physical and engineering sciences

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.074

H-Index - 169

eISSN - 1471-2962

pISSN - 1364-503X

DOI - 10.1098/rsta.2011.0049

Subject(s) - reliability (semiconductor) , regenerative medicine , precision medicine , process (computing) , quality (philosophy) , risk analysis (engineering) , computer science , demographics , manufacturing engineering , clinical practice , emerging technologies , reliability engineering , engineering , stem cell , business , medicine , artificial intelligence , power (physics) , philosophy , physics , demography , epistemology , pathology , quantum mechanics , sociology , biology , genetics , operating system , family medicine

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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