Development Of A High-Dose Engineered Tcr T Cell Manufacturing Process Using Automated Semi-Continuous Perfusion Bioreactors
January 15-19, 2017
Clinical activity with engineered TCR (eTCR) T cell products directed against solid tumor indications may require doses up to two orders of magnitude greater than those investigated during CAR-T studies in hematological malignancies.1 Novel methods for optimizing productivity and production times are required to progress the industrial feasibility of high-dose cell therapies. We developed an automated semi-continuous perfusion culture method suitable for rapidly generating high T cell densities with the aid of risk-based process models. The result is a robust manufacturing process capable of generating a target dose with high certainty, and minimal operational complexity and variability.
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Kenny Choi, Jacob Okhovat, Marianna Sabatino, and Marc Better, "Development Of A High-Dose Engineered Tcr T Cell Manufacturing Process Using Automated Semi-Continuous Perfusion Bioreactors" in "Scale-up and Manufacturing of Cell-based Therapies V", Tom Brieva, Celgene Cellular Therapeutics William Miller, Northwestern University Chris Mason, University College London Eds, ECI Symposium Series, (2017). http://dc.engconfintl.org/cellbasedtherapies_v/109