Scale-up of Wet-Granulation Process: Case Study of a Risk Assessment Based Technology Transfer to Manufacturing Site

Scale-up and transfer to commercial manufacturing site of a high drug load (50%) wet granulation process was successfully implemented by identifying and defining a proven and acceptable range (PAR) for the critical process parameters. Critical quality attributes of the final products were correlated to in-process material attributes during development through implementation of well designed DOEs. Process analytical tools (PAT) and conventional analytical tests were used to characterize these intermediates. The presentation will detail a holistic approach of in-process attribute and parametric controls combined with appropriate finished product tests to successfully scale-up and transfer, process and product to commercial manufacturing site.