BIOT 116 |
| Commercial-scale manufacturing of various therapeutic recombinant proteins involve mammalian cells cultured in bioreactors using a combination of chemically-defined serum-free components and complex medium components. Mammalian cells are sensitive to their hydrodynamic and chemical environment, and a variability in raw materials can significantly impact protein production by the cells. During commercial production of the recombinant proteins, it is often difficult to identify the effects of individual raw materials on cell culture performance due to interactions between components of different raw materials and use of multiple lots of the same raw material during production. We developed and used mathematical models in combination with various statistical tools to simulate the observed titers of a recombinant protein manufactured at different manufacturing facilities. Results from the simulations were used to predict the contribution of individual raw materials and of specific raw material lots, and helped us identify the critical raw material in our manufacturing process. We propose that mathematical tools such as the one presented in this work can be used to identify the critical raw materials and increase understanding of the recombinant protein manufacturing process. |
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Commercialization of Biologics: Data Management & Process Modeling in Support of Commercial Processes
3:00 PM-5:20 PM, Monday, August 20, 2007 BCEC -- 107C, Oral
Division of Biochemical Technology |