May 8-13, 2016
To successfully implement a large scale single-use bioreactor platform, equivalent performance, i.e. scalability, with smaller sized bioreactors across the platform must be demonstrated. With the recent development of a single-use clinical scale (2000 L) bioreactor, the EMD Millipore bioreactor portfolio now spans from the bench-scale (3 L), through the small-scale (50 L) and pilot-scale (200 L) up to the manufacturing process volume range. The performance design space of the entire Mobius® Single-use Bioreactor platform was characterized using several key engineering parameters including oxygen mass transfer coefficient (kLa), power per unit volume, Reynolds number (Re), mixing time and tip speed. Based on a detailed understanding of the dynamic performance capabilities of each bioreactor across the platform, appropriate process parameters can be selected to achieve scalable performance. This presentation will highlight how a detailed understanding of the performance design space of each sized bioreactor can enable the selection of process parameters at each scale that will enable scalable performance across the platform.
Lee Madrid, "Scalability of the Mobius® single-use bioreactor from bench to clinical scale: Examination of key engineering parameters and robustness" in "Cell Culture Engineering XV", Robert Kiss, Genentech Sarah Harcum, Clemson University Jeff Chalmers, Ohio State University Eds, ECI Symposium Series, (2016). https://dc.engconfintl.org/cellculture_xv/150