Process development for improved Car-t production utilizing an automated single use perfusion stirred-tank bioreactor
March 20 – 23, 2022
Ex vivo genetically-modified cellular immunotherapies, such as chimeric antigen receptor T-cells (CAR-T), have generated significant clinical and commercial outcomes due to their unparalleled response rates against refractory/relapsed blood cancers. However, the development and manufacture of these advanced therapies face a number of translational bottlenecks that must be addressed to ensure long-term commercial viability.
The cost and variability associated with these personalized advanced therapies presents a critical manufacturing and translational challenge. Due to the nature of cell therapies, single-use technologies are typically used for their production. This work demonstrates the importance of determining critical manufacturing process parameters using single-use technologies and incorporating automation into the process. The work builds off of previous proof of concept work completed in the group for the production of CAR-T cells in automated, stirred tank, single-use ambr250® bioreactors. These follow-on experiments utilize concepts of quality by design and design of experiments (DoE) to systematically determine the impact of process parameters on CAR-T production.
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Tiffany Hood, Fern Slingby, Quentin Vicard, Nicola Bevan, Viktor Sander, Winfried Geis, and Qasim A. Rafiq, "Process development for improved Car-t production utilizing an automated single use perfusion stirred-tank bioreactor" in "Single-Use Technologies V: Building The Future", Magali Barbaroux, Sartorius, France; Martina Micheletti, University College London, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/sut_v/42