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Simulation of continuous low pH viral inactivation inside a coiled flow inverter
Authors:Laura David  Maximilian P Bayer  Martin Lobedann  Gerhard Schembecker
Institution:1. INVITE GmbH, Chempark, Leverkusen, Germany;2. BCI, Plant and Process Design, TU Dortmund University, Dortmund, Germany
Abstract:Continuous production of monoclonal antibodies is gaining more and more importance. To ensure continuous flow through the entire process as well as viral safety, continuous viral clearance needs to be investigated as well. This study focuses on low pH viral inactivation inside a coiled flow inverter (CFI). Computational fluid dynamics (CFD) simulation is used to gain further insight into the inactivation process inside the apparatus. The influence of viruses in comparison to different tracer elements on the residence time distribution (RTD) behavior is investigated. Finally, the viral inactivation kinetics are implemented into the CFD simulation and real process conditions are simulated. These are compared to experimental results. To the authors' knowledge, this study represents the first successful simulation of continuous viral inactivation inside a CFI. It allows the detailed analysis of processes inside the apparatus and the prediction of experimental virus study results and will therefore contribute to the effective planning of future validation studies.
Keywords:CFD  CFI  continuous processing  low pH  mAb  viral inactivation
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