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Use of Cfd to Identify and Resolve Cell Culture Issues Observed at Production Scale during Technology Transfer

Zhiwu Fang, Systems Informatics, Amgen Inc, One Amgen center Dr, Thousand Oaks, CA 91320

Substantial experimental work has been dedicated to correlating animal cell culture performance to cell culture process conditions. In this work we present a numerical case study on the environment to which cells are exposed in mechanically agitated and sparged bioreactors. For two modeled production scale bioreactors with different designs and process conditions, we compare mechanical shearing force, Reynolds stress, power input per volume, turbulence energy dissipation rate, detrimental Kolmogorov length scale distribution, as well as bubble residence time in impeller zones and tanks. Detailed and complete information was helpful to understand the culture process performance issues encountered during technology transfer, and to consequently identify an optimal operating parameter design space.