Establishment of a WaveTM bioreactor scale-down model for process development and characterization studies

BIOT 268

Sarwat F. Khattak, sarwat.khattak@bms.com1, Sivakesava Sakhamuri, sivakesava.sakhamuri@bms.com1, Zhengjian Li, zhengjian.li@bms.com1, and Steven Lee, steven.lee@bms.com2. (1) Process Development, Technical Operations, Bristol-Myers Squibb, 6000 Thompson Rd, L-2, Syracuse, NY 13057, (2) Biotechnology Development & Operations, Bristol-Myers Squibb Co, PO Box 4755, Syracuse, NY 13221-4755
Process characterization and development studies require the use of scale-down bioreactor models to mimic large-scale cell culture processes. The WaveTM bioreactor was evaluated as an alternative to the stirred-tank bioreactor as a scale-down fed-batch model. The WaveTM bioreactor system is simple to use, low in cost, and is in compliance with cGMP guidelines. Additional advantages of a WaveTM bioreactor over the traditional stirred-tank bioreactor are minimal preparation and cleaning cycles. A WaveTM bioreactor scale-down model could serve as an alternative method to evaluate cell lines and their productivity.

Rocking speed, rocking angle, CO2 delivery, air flow rate and temperature were identified as important process parameters. Process parameters such as pH, pCO2 and air saturation were compared to those of a stirred-tank bioreactor. Cell line performance was evaluated by metabolite analysis, cell growth, and protein characterization. Process parameters and media were optimized to improve productivity and product quality. The results were compared with those of a stirred-tank bioreactor. We present here a case study of the WaveTM bioreactor as a scale-down model which has similar performance in terms of productivity and product quality attributes to those of a stirred-tank bioreactor.

 

Poster Session
5:30 PM-7:30 PM, Wednesday, August 22, 2007 BCEC -- Exhibit Hall - B2, Poster

Division of Biochemical Technology

The 234th ACS National Meeting, Boston, MA, August 19-23, 2007