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Automated Counterflow Centrifugal System for Small-Scale Cell Processing
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Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions.

Sally Hassan1, Ana S Simaria1, Hemanthram Varadaraju2,3

  • 1The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Gordon Street, London WC1H 0AH, UK.

Regenerative Medicine
|August 4, 2015
PubMed
Summary

Developing a cost-effective process for allogeneic cell therapies requires careful selection of manufacturing technologies. This tool aids in identifying optimal flowsheets for cell expansion and downstream processing (DSP) across various production scales.

Keywords:
allogeneic cell therapy manufacturebioprocess economicscentrifugationdownstream processingfillingtangential flow filtration

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Area of Science:

  • Biotechnology
  • Process Engineering
  • Cell Therapy Manufacturing

Background:

  • Allogeneic cell therapies offer significant therapeutic potential but face manufacturing challenges.
  • Optimizing production processes is crucial for cost-effectiveness and scalability.
  • Current process development lacks comprehensive tools for economic evaluation.

Purpose of the Study:

  • To create a decision-making tool for identifying cost-effective process flowsheets for allogeneic cell therapies.
  • To evaluate competing cell expansion and downstream processing (DSP) technologies.
  • To analyze process economics across a range of production scales.

Main Methods:

  • Development of a bioprocess economics and optimization tool.
  • Assessment of various cell expansion and DSP technologies.
  • Economic modeling of different manufacturing scales and process configurations.

Main Results:

  • Tangential flow filtration is cost-effective for lower cell yields from planar technologies.
  • Fluidized bed centrifugation is essential for large bioreactor outputs.
  • Downstream processing (DSP) represents a significant cost (20-55% for planar, 50-80% for bioreactor flowsheets) and can be a bottleneck at large scales.

Conclusions:

  • The developed tool facilitates early-stage decision-making in process development.
  • Informed choices in process flowsheets can improve the economic viability of allogeneic cell therapies.
  • Optimization of DSP is critical for large-scale cell therapy manufacturing.