: Development, Optimization, and Scale up of a Human Growth Hormone PEGylation Process

A history of the development and scale up of the process for PEGylation of human growth hormone is described. The development of the PEGylation procedure from initial discovery process through commercial scale up for production of clinical supply materials is described. Optimization of process chemistry, including reagent selection and condition optimization are described. Development and application of a kinetic model for the reaction and its application to prediction of optimum process conditions is described.