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Polyclonal Regulatory T Cell Manufacturing Under cGMP: A Decade of Experience
Joanna Balcerek1, Brian R Shy1, Amy L Putnam2
1Department of Laboratory Medicine, University of California San Francisco, San Francisco, CA, United States.
Frontiers in Immunology
|December 6, 2021
Summary
Manufacturing polyclonal regulatory T cell (PolyTreg) products for clinical trials shows high success rates. Over 80% of PolyTreg products met release criteria and were infused, demonstrating consistent outcomes.
Area of Science:
- Immunology
- Cell Therapy Manufacturing
- Clinical Trials
Background:
- Autologous polyclonal regulatory T cells (PolyTreg) are utilized in various Phase 1 clinical trials.
- Consistent manufacturing outcomes are crucial for the success of cell-based therapies.
Purpose of the Study:
- To evaluate the manufacturing outcomes of autologous PolyTreg products over a 10-year period.
- To identify factors influencing PolyTreg manufacturing success and cell expansion.
Main Methods:
- Analysis of manufacturing batch records from 41 PolyTreg products across 7 clinical trials (2011-2020).
- Data collection included patient characteristics, manufacturing parameters, and release criteria.
- Statistical analysis to correlate manufacturing outcomes with various parameters.
Main Results:
- 88% of PolyTreg products met release criteria, and 83% were successfully infused.
- Median fold expansion was 434.8-fold over 14 days, with a median post-expansion count of 1.841 x 10^9 cells.
- Starting cell number was the primary correlate of post-expansion cell count; other factors showed no significant correlation.
Conclusions:
- PolyTreg manufacturing demonstrates consistent and reliable outcomes across different trials and production dates.
- The manufacturing process is robust, with high success rates for producing T regulatory cells for clinical use.
