At the 2010 American Institute of Chemical Engineers (AIChE) Annual Meeting in Salt Lake City, there were a number of well-attended sessions dealing with the related topics of Quality by Design (QbD) and Process Analytical Technologies (PAT).
Recently, I guest authored a simplified view of QbD and PAT in the PharmaQbD blog entitled If QbD is the Map, then PAT is the GPS. That blog post was based on the point that QbD and PAT are most effective when applied in a complimentary fashion. At AIChE, there were many good examples based on using a process model – developed from QbD experiments – being applied in late process development and manufacturing for real-time monitoring and control in accordance with the PAT guidance.
Many discussions focused on continuous processing in drug product manufacturing show clear advancement in pharmaceutical manufacturing technology. However these advancements also confirm the need for process understanding (from QbD) to go hand-in-hand with process monitoring (a key element of PAT). For example, the continuous monitoring of the particle size distribution in roller compaction was shown in a number of talks to provide the potential ability to measure and control a key critical quality attribute. Particle (granule) size directly impacts powder flowability and compressibility and in turn impacts the bioavailability of the drug substance through its effect on the dissolution/disintegration profiles of the final dose.
If you are interested in the application of Process Analytical measurements for real-time understanding of particle and granulation systems, I would point you to a couple of free on-demand webinars that are available:
- Fluid Bed with Inline FBRM® C35: A Predictor of Dissolution Quality (Presented by Dr. Steve Mehrman, Johnson & Johnson)
- Roller Compaction Process Optimization Using At-Line Particle Characterization (Presented by Dr. Des O’Grady, METTLER TOLEDO)