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Process change evaluation framework for allogeneic cell therapies: impact on drug development and commercialization
Sally Hassan1, Hsini Huang2, Kim Warren3
1Department of Biochemical Engineering, The Advanced Centre for Biochemical Engineering, University College London, Gordon Street, London, WC1H 0AH, UK.
Regenerative Medicine
|March 17, 2016
Summary
Switching cell expansion technology to microcarriers earlier in development minimizes costs for allogeneic cell therapies. A later switch may offer higher risk-adjusted net present value by leveraging initial market entry.
Area of Science:
- Biotechnology
- Process Development
- Cell Therapy Manufacturing
Background:
- Allogeneic cell therapies often require high cell doses, necessitating scalable expansion technologies.
- Transitioning from planar to microcarrier-based systems in single-use bioreactors is crucial for market-phase manufacturing.
- Optimizing the timing of this technology switch is key for economic viability.
Purpose of the Study:
- To model the optimal timing for transitioning cell expansion technology from planar to microcarriers.
- To evaluate the economic implications of process changes at various stages of a cell therapy's lifecycle.
Main Methods:
- Development of a cash flow framework modeling the cell therapy development lifecycle.
- Analysis of process change implications at different lifecycle stages, focusing on microcarrier implementation.
Main Results:
- Earlier adoption of microcarrier technology is optimal for minimizing total expected out-of-pocket costs.
- Switching during Phase I development is economically competitive.
- A post-approval switch can yield the highest risk-adjusted net present value due to initial market penetration with existing planar technologies.
Conclusions:
- The developed framework aids in early decision-making for process development strategies.
- Strategic timing of technology transitions is critical for optimizing cell therapy manufacturing economics.
