title: Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions.
abstract: OBJECTIVE
  To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales.
  
  
  METHODS
  A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies.
  
  
  RESULTS
  Tangential flow filtration was generally more cost-effective for the lower cells/lot achieved in planar technologies and fluidized bed centrifugation became the only feasible option for handling large bioreactor outputs. DSP bottlenecks were observed at large commercial lot sizes requiring multiple large bioreactors. The DSP contribution to the cost of goods/dose ranged between 20-55%, and 50-80% for planar and bioreactor flowsheets, respectively.
  
  
  CONCLUSIONS
  This analysis can facilitate early decision-making during process development.
authors.affiliation: The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Gordon Street, London WC1H 0AH, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Hassan
authors.affiliation: The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Gordon Street, London WC1H 0AH, UK.
authors.forename: Ana S
authors.initials: AS
authors.lastname: Simaria
authors.affiliation: Development Services, Cell Therapy, Lonza Walkersville, Inc., 8830 Biggs Ford Road, US - 21793-0127 Walkersville, MD, USA.|Modern Meadow, 140 58 Street Building A, Suite 8J Brooklyn, NY 11220, USA.
authors.forename: Hemanthram
authors.initials: H
authors.lastname: Varadaraju
authors.affiliation: Development Services, Cell Therapy, Lonza Walkersville, Inc., 8830 Biggs Ford Road, US - 21793-0127 Walkersville, MD, USA.
authors.forename: Siddharth
authors.initials: S
authors.lastname: Gupta
authors.affiliation: Development Services, Cell Therapy, Lonza Walkersville, Inc., 8830 Biggs Ford Road, US - 21793-0127 Walkersville, MD, USA.
authors.forename: Kim
authors.initials: K
authors.lastname: Warren
authors.affiliation: The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Gordon Street, London WC1H 0AH, UK.
authors.forename: Suzanne S
authors.initials: SS
authors.lastname: Farid
mesh_terms: D019149:Bioreactors / Q000191:economics*; D018929:Cell Culture Techniques; D049109:Cell Proliferation; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D003362:Cost-Benefit Analysis; D003657:Decision Making; D006801:Humans; D007221:Industry; D059630:Mesenchymal Stem Cells; D044968:Regenerative Medicine / Q000191:economics*; D033581:Stem Cell Transplantation / Q000191:economics; D014184:Transplantation, Homologous
keywords: allogeneic cell therapy manufacture; bioprocess economics; centrifugation; downstream processing; filling; tangential flow filtration