Troubleshooting During Drug Product Development – Utilizing DEM for Root Cause Analysis

Developing a drug into a drug product is a challenging and time-consuming undertaking. In particular, transferring the drug product manufacturing process from development to production scale is exceptionally critical and sometimes associated with unforeseen issues, which are only occurring in larger scales. Additionally, changes in material properties can heavily impact the processability of the material, but the significance of certain changes is often not easily predictable. In both cases, DEM has proven itself to be valuable in providing insights and identifying root causes for certain observations during drug product development.

Presented as part of the virtual ATCx DEM in November 2022.
Speaker: Dr. Karsten Flügel, Principal Scientist, Merck Healthcare KGaA
Duration: 20 minutes