Application Note: Integrating Automation and DOE to streamline and Accelerate Quality by Design Activities for Process Chemistry
19 September 2018
Getting drugs to market is hard. Modern drug development organizations face many business and environmental challenges. Billions of dollars are spent on new molecules or vaccine discoveries that can fail at any point in development, during the manufacturing process or in clinical trials. It is critical to design safe drug products and develop robust processes that minimize project risk as a candidate moves through development, out to the plant and into humans. In addition, in the eyes of the regulator, the application of Quality by Design (QbD) principals will soon become mandatory in drug submissions.