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Integrating Automation and DOE to Streamline and Accelerate Quality by Design Activities for Process Chemistry

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. 

The International Conference on Harmonization (ICH) Tripartate guidelines for the implementation of QbD in the pharmaceutical industry (ICH Q8, Q9 and Q10) state: 

- Products must be designed to meet patient safety and efficacy needs and performance requirements

- Processes must be designed to consistently meet product quality attributes

- The impact of starting raw materials and pro¬cess parameters on product quality must be understood

- Critical sources of process variability must be identified and controlled

- The process is continually monitored and updat¬ed to allow for consistent quality over time and to have a stable process