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2013 Fall Departmental Research Seminar Title: Development of Therapeutic Protein Production Platform by Rational Host Cell Engineering Time: 14-Nov, Thursday 11:25~11:50 am. Place: SERC 1014 (coffee and snacks will be provided) Speaker: Ningning Xu Ph.D. Pre-Candidate Abstract: Due to the high risk and high cost to develop innovative biopharmaceutical, the interest in developing biosimilar, i.e. the generic therapeutic protein that is “similar to an existing reference biological medicine”, with promising market size has increased. However, the lack of an in- depth understanding of the rational regulation of post translation modification and producing cell line stability hampered the development of biosimilar. The overall goal of this research is to create a platform to rationally design and produce generic biopharmaceuticals using Chinese Hamster Ovary (CHO) cell. First, high producing cell lines with desired features will be constructed using multiple host cells to produce monoclonal antibody (mAb, e.g. IgG 1) that aims at the treatment of human cancer (e.g. breast cancer). Second, systems biology (Omics) will be applied to develop a deep understanding of global protein expression map, metabolic profiling, and transcriptomics and identify the host cell regulators. Third, the targeting regulation and synthetic biology will be applied to rationally engineer host cell to manipulate protein quality (i.e. glycosylation and sialylation) and protein expression stability. Fourth, integrated production process will be developed to produce mAb using the engineered cell line. Finally, animal study (or clinical trial) will be performed to test the efficiency of the therapeutic protein produced using the developed platform. The achievement of this research could accelerate the development and commercialization of other biosimilars and innovative biopharmaceuticals. Biography: Ningning Xu is a first-year Ph.D. student in the Department of Chemical and Biological Engineering at The University of Alabama (July 2013 - present). She worked as an Auto-Office Equipment and Consumables Validation Engineer in the National Supervising and Testing Center, Tianjin, China, (2009 - 2011). She received her Bachelor degree in the School of Chemical Engineering and Technology at Tianjin University, Tianjin, China (2005 - 2009).

2013 Fall Departmental Research Seminar - che.eng.ua.eduche.eng.ua.edu › files › 2013 › 07 › ningning_xu_development_of_thera… · Ningning Xu is a first-year Ph.D. student

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    2013 Fall Departmental Research Seminar

    Title: Development of Therapeutic Protein Production Platform by Rational Host Cell Engineering Time: 14-Nov, Thursday 11:25~11:50 am. Place: SERC 1014 (coffee and snacks will be provided) Speaker:

    Ningning Xu Ph.D. Pre-Candidate Abstract: Due to the high risk and high cost to develop innovative biopharmaceutical, the interest in developing biosimilar, i.e. the generic therapeutic protein that is “similar to an existing reference biological medicine”, with promising market size has increased. However, the lack of an in-depth understanding of the rational regulation of post translation modification and producing cell line stability hampered the development of biosimilar. The overall goal of this research is to create a platform to rationally design and produce generic biopharmaceuticals using Chinese Hamster Ovary (CHO) cell. First, high producing cell lines with desired features will be constructed using multiple host cells to produce monoclonal antibody (mAb, e.g. IgG 1) that aims at the treatment of human cancer (e.g. breast cancer). Second, systems biology (Omics) will be applied to develop a deep understanding of global protein expression map, metabolic profiling, and transcriptomics and identify the host cell regulators. Third, the targeting regulation and synthetic biology will be applied to rationally engineer host cell to manipulate protein quality (i.e. glycosylation and sialylation) and protein expression stability. Fourth, integrated production process will be developed to produce mAb using the engineered cell line. Finally, animal study (or clinical trial) will be performed to test the efficiency of the therapeutic protein produced using the developed platform. The achievement of this research could accelerate the development and commercialization of other biosimilars and innovative biopharmaceuticals.

    Biography: Ningning Xu is a first-year Ph.D. student in the Department of Chemical and Biological Engineering at The University of Alabama (July 2013 - present). She worked as an Auto-Office Equipment and Consumables Validation Engineer in the National Supervising and Testing Center, Tianjin, China, (2009 - 2011). She received her Bachelor degree in the School of Chemical Engineering and Technology at Tianjin University, Tianjin, China (2005 - 2009).