Predictive Scale-Up/Scale-Down for Biopharmaceuticals

Scale-up/scale-down is essential in the process development and production in pharmaceuticals and biopharmaceuticals industry. Successful scale-up/scale-down of a process requires understanding of key relevant driving forces for reactions and physical transformations, as well as mass and heat transport phenomena. Application of process simulation/modeling tools (CFD, Dynochem, gPROMS, and etc.) can greatly benefit the process understanding in terms of kinetics/thermodynamics and facilitates establishment of scale-up/scale-down strategies. While, 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 manufacturing 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.