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Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies
Ana S Simaria1, Sally Hassan, Hemanthram Varadaraju
1Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Torrington Place, London, WC1E 7JE, UK.
Biotechnology and Bioengineering
|July 30, 2013
Summary
Scalable manufacturing of allogeneic cell therapies requires cost-effective expansion. A new tool assesses planar and microcarrier technologies, identifying needs for microcarrier system improvements to meet commercial demands.
Area of Science:
- Biotechnology
- Process Engineering
- Cell Therapy Manufacturing
Background:
- Allogeneic cell therapies require scalable and robust manufacturing processes to meet commercial demands.
- Current expansion technologies face limitations in producing large lot sizes (10^9 cells/dose).
Purpose of the Study:
- To apply a decisional tool for identifying cost-effective cell expansion technologies for allogeneic cell therapy manufacture.
- To assess current technology gaps and guide future R&D investment.
Main Methods:
- Integrated bioprocess economics with optimization to compare planar and microcarrier-based expansion technologies.
- Utilized visualization methods, including technology S-curves and windows of operation, to analyze cost-effectiveness at different production scales.
Main Results:
- Identified production scales where planar technologies become less cost-effective than microcarrier-based bioreactors.
- Predicted the need for significant performance improvements in microcarrier systems for high-demand scenarios.
- Determined optimal combinations of cell productivity and single-use bioreactor scale for future lot sizes.
Conclusions:
- The developed decisional tool aids early-stage decision-making in cell therapy process development.
- Future R&D investment should focus on enhancing microcarrier system performance for scalable and robust allogeneic cell therapy manufacturing.
- Addressing these manufacturing challenges is crucial for realizing the therapeutic potential of allogeneic cell therapies.
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