Wednesday, August 1, 2007 - 10:30 AM
S135

Rapid and Efficient Attainment of Optimized Process Development

Yongping Yang, Vinay V. Vyas, Yueqing Xie, Robert Testerman, George Mitra, and Jianwei Zhu. Biopharmaceutical Development Program, SAIC Frederick and National cancer Institute at Frederick, Building 432, Room208, Wood Street,, P O Box B, Frederick, MD 21702

The capacity of process development to meet high expression and high quality of therapeutic proteins remains a key issue. Applying the cellferm-pro system (DASGIP AG, Julich, Germany), a novel process optimization tool, we rapidly and efficiently accomplished the optimization of mammalian cell culture medium, feeding strategy and bioreactor process design. As compared with the original process, the optimized process with this system increased the productivity levels up to six times, which significantly improved the therapeutic protein productivity and quality. In addition, the mammalian cell culture process condition optimized with the cellferm-pro system is easily able to scale up for GMP-based large-scale production process. Because of its high experimental throughput capacity, The cellferm-pro system has been demonstrated to have enormous potential for efficient and reliable process development, optimization and validation of biopharmaceutical processes.