Publication Date: Thu Nov 16 00:00: Research Org.: Oak Ridge Inst. of Massachusetts, Lowell, MA (United States). Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II Univ. Food and Drug Administration (FDA), Silver Spring, MD (United States). Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II This work highlights the utility of high throughput micro bioreactors and the importance of identifying both positive and negative impacts of media and antifoam selection on a model IgG1 producing CHO cell line. Antifoams C, EX-Cell, and SE-15 more ยป were capable of providing adequate control of foaming while antifoam 204 and Y-30 noticeably stunted cellular growth. This study found ProCHO5, EX-Cell Advanced, and PowerCHO2 media supported strong cellular growth profiles, with an IVCD of 25-35 3 106 cells-d/ mL, while maintaining specific antibody production (Qp> 2 pg/cell-d) for our model cell line and a monomer percentage above 94%. Here, we utilized a micro-scale parallel bioreactor system to study an IgG1 producing CHO cell line, to screen Dynamis, ProCHO5, PowerCHO2, EX-Cell Advanced, and OptiCHO media, and 204, C, EX-Cell, SE-15, and Y-30 antifoams and their impacts on IgG1 production, cell growth, aggregation, and process control. High throughput screening in micro-scale bioreactors provides an efficient strategy to identify initial operating parameters. Silicone polymer-based antifoams were known to have negative impacts on cell health, production, and downstream filtration and purification operations. While cell culture media selection is of obvious importance to the health and productivity of mammalian bioreactor operations, other components such as antifoam selection can also play an important role in bioreactor cell culture. It is important to identify high impact components early on during the lifecycle of a biotechnology-derived product. Monoclonal antibody production in commercial scale cell culture bioprocessing requires a thorough understanding of the engineering process and components used throughout manufacturing.
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