MIXING AND FLUID DYNAMICS CHARACTERISTICS IN SINGLE-USE BIOREACTORS FOR IMPROVED DESIGN AND SCALABILITY

摘要

The pharmaceutical industry is at the forefront of the production of antibodies using mammalian cell-based cultures, with single-use technologies gaining prominence in the manufacturing process. Since the development of the first rocked bag bioreactor in 1997, other novel designs have been developed such as orbitally shaken, two and three dimensionally rocked, pneumatically driven, in addition to inflated cylindrical stirred bags. These have the potential to address new applications like expansion of adult stem cells for allogeneic therapies approaches by providing sufficient mixing while controlling maximum shear stress levels. Rigorous fluid dynamics studies are needed to understand the flow behaviour at different operating conditions, be able to determine meaningful dimensionless characteristics and establish robust scaling laws. A combination of different advanced analytical techniques were used to determine mixing and velocity characteristics and the validity of the approach is demonstrated by three case studies looking at different bioreactor flows relevant to bioprocessing.