Connecting Processed Material’s Properties to Process Development Strategy

A quality-by-design (QbD) process development case study would be presented using an example of a high drug load wet granulation formulation. This case study will identify the dependence of drug product performance quality attributes on material properties of intermediate granules. The translation of this mechanistic product and process understanding to process development, process analytical technology (PAT), and process control will be highlighted. The correlation of granule size versus porosity with tablet dissolution will be discussed. The implications of this correlation on the use of focused beam reflectance measurement (FBRM) versus drag flow force (DFF) sensor for process monitoring and control will be discussed. This talk will highlight the importance of material understanding to process development.