Abstract
It has been well recognized that biologics are efficient for cancer and immune disease treatment. Kinetic modeling is to mathematically model or to quantitatively illustrate how reactions occur in a biological or chemical process. A systematic study and understanding of kinetic model and its application in the biopharmaceutical industry are important for both scientific research and industrial technology development. This work consists of six chapters. First, a review of kinetic modeling and its application for cell culture was introduced. Second, the current status of biologics development and screening strategies of biomarkers and indications were discussed. Third, one experimental and kinetic modeling study for the temperature effects and temperature shift strategy development was presented. Forth, novel kinetic models were built up and applied to elucidate lactate dehydrogenase catalyzed reactions, which is a crucial metabolic process within tumor cells and Chinese hamster ovary cells. In the fifth chapter, strategies of biologics quality control via process development were briefly summarized. And finally, summary and outlook were made based on the above five chapters. Though kinetic modeling is not a FDA request tool, kinetic data are required for regulation approval of new drug discovery and process development. These data are applicable for a rapidly screening of the best biologics and the optimized manufacturing process with little extra cost via kinetic modeling. This work is potentially beneficial for speeding up and better understanding of the current biologics development in biopharmaceutical industry.