(632e) Reaction Kinetic Modeling in the Development of Human Growth Hormone PEGylation Process

Reaction kinetic study of the PEGylation of human growth hormone was carried out as part of the development of this important step in the overall production process. Based on experimental characteristics of the actual reaction system as well as selected model reactants, a general kinetic model was constructed that included formation of product and by-products as well as the stability of the PEG reagents themselves. With its ability to fit the kinetic data for all key reaction species very well under various conditions, the model became an effective tool for exploring mechanistic significance of key reaction parameters, providing a quantitative basis for comparison of available PEG reagents, and ensuring true optimal reaction conditions were obtained without extensive and time-consuming experimentation.