title: Current understanding and challenges in bioprocessing of stem cell-based therapies for regenerative medicine.
abstract: BACKGROUND
  A novel manufacturing industry is emerging to translate unique cellular therapy bioprocesses to robust, scaled manufacturing production for successful clinical translation.
  
  
  METHODS
  This review summarizes key translational issues, and current and future perspectives to improve translation of cell-based therapy bioprocessing, based on literature search and author research.
  
  
  RESULTS
  It is widely recognized that cell-based therapies could revolutionize health care for a range of diseases, and that there are gaps in the overarching framework and technologies to generate clinical success.
  
  
  RESULTS
  There is limited understanding of how to fulfil requirements as regulatory and manufacturing guidelines are incomplete and few have achieved commercialization.
  
  
  CONCLUSIONS
  Recent developments are encouraging adoption of automation and quality engineering approaches for bioprocessing of cell-based therapies.
  
  
  CONCLUSIONS
  Include technology development to improve the cost and purity of manufacture and final product quality.
authors.affiliation: Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering, Loughborough University, Loughborough, LE11 3TU, UK. e.ratcliffe@lboro.ac.uk
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ratcliffe
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Thomas
authors.forename: David J
authors.initials: DJ
authors.lastname: Williams
mesh_terms: D001331:Automation / Q000379:methods; D006801:Humans; D044968:Regenerative Medicine / Q000379:methods / Q000639:trends*; D033581:Stem Cell Transplantation / Q000379:methods / Q000639:trends*; D023822:Tissue Engineering / Q000379:methods / Q000639:trends; D057170:Translational Research, Biomedical / Q000379:methods