BIOne SUB: A Commercially Viable Strategy for Cell Therapy Manufacturing

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Distek, Inc.

Stirred-tank bioreactors present an option for the expansion of primary human T-Cells that has previously not been pursued due to concerns about shear stress. Small scale studies have shown that impeller driven mixing stirred-tank bioreactors do not increase cell death or limit expansion potential. Translating the learnings from those small scale studies to the autologous manufacturing scale has shown that the BIOne stirred-tank bioreactor produces a consistent culture environment and high cell yields. The BIOne significantly outperformed rocking bioreactor systems in both total yield and production efficiency.