Session: Predictive Scale-up/Scale-down for Production of Pharmaceuticals and Biopharmaceuticals I

The demand to meet quality standards and increased speed-to-market for pharmaceutical processes, necessitates mechanistic understanding of these processes. Successful scale-up/scale-down of a process requires an understanding of key relevant kinetic and thermodynamic driving forces. First-principle mechanistic understanding of relevant kinetics are impacted by selected equipment and operational constraints. Additionally, operational issues at scale such as out-of-specification investigation, new impurity, homogeneity issues, new equipment selection, etc. require a systematic scale-down approach to lab-scale to better understand the commercial scale environment and develop solutions. These challenges are found in both batch and continuous processes for the chemical and biological synthesis of drug substance and drug product. Contributions that cover theoretical approaches to and / or demonstrated implementation of scale-up/scale-down analysis for drug substance of small molecules, antibody-drug conjugates, or biological products are encouraged for submission to be considered for oral presentation.