Advanced Digitalization Plan for AstraZeneca's CDC line

As continuous processes are sensitive to temporary disturbances potentially affecting drug product quality, regulators require real-time quality monitoring during the manufacturing run. Currently, most oral solid dose applications are focused on measuring the blend homogeneity in the tablet press feed frame by NIR spectroscopy and/or predicting API content in the tablet using process models.

This approach enables to divert potentially non-compliant tablets in real-time hence assuring product quality. However, current approaches do not enable to identify of root causes for the observed quality disturbances and therefore no corrective actions can be performed to ensure optimal process performance.

Moreover, this set-up does not enable it to react to small changes in input material properties and/or process conditions. At AZ we are planning to equip our CDC line with an extended digital platform containing real-time PAT management, real-time data analytics and advanced process control capabilities.

An overview of the planned set-up will be provided as well as a discussion on how the different tools will work in symbiosis to provide consistent product quality, high process robustness and optimal process performance.