Monday, November 9, 2009 - 8:25 AM
S8

Single-Use Bioreactor Evaluation:  Comparable Culture Performance Demonstrated in Pilot Scale Wave-Mixing and Stirred Bag Bioreactors

Will A. Miller, Bruce Bishop, and Shamik Sharma. Pfizer, CA

The utilization of single-use bioreactors (SUB’s) has rapidly expanded throughout the bioprocessing industry, while the design and type of SUB technology has proliferated as well.  SUB’s have been primarily employed for mammalian cell, insect cell and vaccine production processes, and, in context with these applications, have demonstrated performance analogous to stirred tank reactors (STR’s).  However, performance comparability amongst the various SUB designs, in particular wave-mixing and stirred bag bioreactor systems, has yet to be established for cell culture processes.  In this study, a side-by-side evaluation of two SUB technologies was conducted using a CHO cell culture process for mAb production.  Pilot scale STR, Wave® and Hyclone S.U.B. bioreactors were compared, with the STR used as a control.  Working volumes for each bioreactor type were, 100L, 100L and 160L, respectively.  The bioreactors were analyzed in regards to their impact on CHO cell growth, cell metabolism, mAb production and mAb product quality.  Comparable results for these process performance attributes were achieved for both the Wave® and Hyclone S.U.B. bioreactors as compared to the STR production process.  These results demonstrate comparability of performance and reproducibility of CHO cell cultivation and mAb production in pilot scale Wave® and Hyclone S.U.B. bioreactors.  Additionally, an overview of SUB systems will be discussed.