Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions

To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. Tangential fl...

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Bibliographic Details
Published in:Regenerative medicine 2015-08, Vol.10 (5), p.591-609
Main Authors: Hassan, Sally, Simaria, Ana S, Varadaraju, Hemanthram, Gupta, Siddharth, Warren, Kim, Farid, Suzanne S
Format: Article
Language:English
Subjects:
allogeneic cell therapy manufacture
bioprocess economics
Bioreactors - economics
Cell Culture Techniques
Cell Proliferation
Cell- and Tissue-Based Therapy - methods
centrifugation
Cost-Benefit Analysis
Decision Making
downstream processing
Economic aspects
filling
Humans
Industry
Medical economics
Mesenchymal Stromal Cells
Regenerative Medicine - economics
Stem cell research
Stem cell transplantation
Stem Cell Transplantation - economics
tangential flow filtration
Transplantation, Homologous
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Summary:To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. 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. This analysis can facilitate early decision-making during process development.
ISSN:1746-0751
1746-076X
DOI:10.2217/rme.15.29