In recent years, continuous Virus Inactivation (cVI) has attracted significant attention in the biopharmaceutical industry due to the growing interest in end-to-end continuous downstream processing.  Introduction of cVI allows continuous downstream operation while reducing footprint, operational handling and improved control. When converting to a continuous unit operation, a tightly controlled residence time element to effectively inactivate viruses and reduce the risk of aggregation is needed. The system must be designed with sufficient robustness to handle changes to flowrate, titer, and pH along with short pauses. It’s essential to have the narrowest possible RTD to allow for the widest operating range. A Coiled Flow Inverter (CFI) is used to create a narrow Residence Time Distribution (RTD) to ensure material remains at low pH for sufficient time required for patient safety.<br/>Previous work in the area of CFI design has primarily been guided by two dimensionless parameters; Dean’s number and Modified Torsion number. However, other aspects like number of turns around a coil, redundant sensors and interaction between variables are not captured in its entirety with this method. This work explores the effect of different variables including flowrate, tube diameter, coil diameter, number of turns around a coil and the presence of in-line sensors on relative RTD. Using multivariant experimental design an empirical model was created to significantly reduce the RTD of the reactor compared to the use of the dimensionless parameters alone. <br/>

Looking beyond dimensionless numbers for a robust continuous virus inactivation process

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.