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 us to divert potentially non-compliant tablets in real-time, thereby assuring product quality. However, current approaches do not enable the identification of root causes for the observed quality disturbances and therefore no corrective actions can be performed to ensure optimal process performance. Moreover, this setup 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.

Presented by Melanie Dumarey, Product and process design engineer (associate principal scientist) at AstraZeneca

Melanie Dumarey obtained her PhD in pharmaceutical sciences at the Vrije Universiteit Brussel (Belgium), where she specialized in data analytics for pharmaceutical applications. At GSK, she used those skills to support QbD applications for drug substance development. Moreover, she developed a real-time multivariate monitoring application to support continuous drug substance manufacturing and led the implementation of the resulting predictive maintenance strategy for the first commercial product. In 2019 she joined AstraZeneca, where she is leading the digitalization program for the newly acquired continuous direct compression (CDC) line as well as managing all control strategy-related activities for the CDC.