(216e) How to Improve Biopharmaceutical Production Efficiency Using Integrated Bioprocessing?

In the last decade of mammalian bioprocess development with novel medium and nutrient feed design, antibody titers in excess of 1 g/L have been achieved. However, it is still a challenge to consistently and rapidly construct a stable biopharmaceutical producing cell line and develop an efficient production bioprocess capable of supporting both high therapeutic protein yield and acceptable antibody glycosylation profile. To overcome these bottlenecks, it is highly desired to develop a novel bioprocessing strategy using advanced technologies, for example, integrating host cell engineering, systems biology and bioreactor process optimization to improve the bioprocess efficiency of therapeutic proteins. CHOnomics technology, including genomics, metabolomics and transcriptomics, can be applied to globally understand CHO metabolic profiling and genome transcription, and to identify the key metabolic activity and regulation genes or elements. The potential application of multiple cell engineering strategies in engineering CHO cell to achieve novel phenotypes will be discussed. The integrated bioprocessing can efficiently improve the biopharmaceuticals production by combining metabolite nutrient development, high producing cell line construction and bioreactor process optimization. Using the integrated bioprocessing technology, it is expected to achieve stable antibody production from gene with titer of 1-3g/L within 6 months. Finally, the development of a robust and scalable cell culture production process is critical in biopharmaceutical manufacturing to maintain both high protein productivity and high protein quality.