Scalability of Mobius~R CellReady Stirred-Tank Bioreactors

摘要

EMD Millipore has developed a family of single-use bioprocess containers designed for mammalian cell growth and recombinant protein production. The Mobius~R CellReady product offering includes bench-scale (3-L), small-scale (50-L) and pilot-scale (200-L) bioreactors spanning early process development through clinical batch production. To enable the successful scale-up of a biomanufacturing process, a number of factors critical to efficient cell growth, viability, and protein production were considered and used to develop an optimized design. These include mixing efficiency, gas transfer capability, and an operating range of power input that minimizes cell shear. In this study, several key design parameters such as oxygen mass transfer coefficient {kLa), power per unit volume, Reynolds number (Re), mixing time, and tip speed were characterized for the three different sized single-use bioreactor containers. Based on these data, CHO cells were cultured in each of these bioreactors by maintaining equivalent power per unit volume as the primary scaling parameter. The collective characterization and performance data provide evidence of cell culture scalability across the entire Mobius~R CellReady bioreactor platform.