Predictive Scale-Up/Scale-Down for Production of Pharmaceuticals and Biopharmaceuticals

Batch processing in the pharmaceutical industry involves a series of unit operations where the synthesis and downstream processing of the chemical or biological product takes place in conjunction with mass, heat and momentum transfers. All of these processes are scale dependent and typically involve scaling-up from lab equipment to pilot scale and eventually to commercial scale operation. Similarly, operational issues experienced at commercial scale manufacturing (out of specification investigation, new impurity, raw material vendor change etc.) require a systematic scale-down approach to the lab scale in order to reproduce and investigate manufacturing problems before implementing solutions. Using predictive, first-principle based modeling as a guide during scale-up/scale down not only reduce the experiment cost with improved efficiency but also tremendously improve the process understanding which leads to better process control and improved product quality. This session invites papers that cover both theoretical and applicable aspects of scale-up/scale-down analysis across drug substance and drug product processes for small molecules as well as biological products.