Scalability From Mobius® 3 L Single-Use Bioreactor To 50-2000 L Mobius® iFlex Bioreactors To Support Intensified Upstream Process Development

By Marisa Maher, Samantha Whitney, Jonathan Cain, Amy Wood, MilliporeSigma, Bedford, MA, USA

Properly scaling from Mobius® 3 L Single-Use Bioreactors to Mobius® iFlex Bioreactors for intensified processes is highly dependent on maintaining mixing, oxygenation, nutrient, and process control. To be able to meet these criteria, bioreactor systems need to have a well-characterized design space while considering risks and ways to control hydrodynamic shear. Extensive understanding of the bioreactor design space and the environmental conditions experienced by the cells within the systems’ operating range enables more informed process development and predictable performance across scales.

The Mobius® 3 L Single-Use Bioreactor and the 50-2000 L Mobius® iFlex Bioreactors are designed for efficient cell growth of batch, fed-batch, and perfusion upstream processes. The bioreactors are optimized for high volumetric mass transfer (kLa) and power input (W/m3) with low mixing time while balancing shear limits through impeller tip speed and sparger bubble size.

In this study, key parameters of power input, power number, mixing time, tip speed, and shear calculations for the Mobius® 3 L Single-Use Bioreactor and the 50-2000 L Mobius® iFlex Bioreactor impeller designs were characterized. Additionally, kLa and bubble size from all available sparger designs were characterized to help understand bubble shear impact when scaling from 3 L to Mobius® iFlex Bioreactors. Lastly, CO2 stripping efficiency was assessed to understand trends per sparger type during scale-up.