Process Analytical Technology (PAT) refers to a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality attributes and performance attributes, with the goal of ensuring final product quality.

PAT implementation at Hovione is under the responsibility of a global support group established over 15 years ago, serving both development and commercial stages across all Hovione sites.

During process development, the goal of using PAT is to achieve a better understanding of our processes and the effect of scale-up.

The use of PAT for commercial manufacturing happens in the context of the control strategy and aims for a better control of the process.

The advantages of using PAT are fully achievable in the context of a Quality by Design approach to process development and can include:

• Improved quality metrics such as right first time ratios
• Less process variability within and between batches
• Reduced costs of development and manufacturing
• Higher supply chain reliability

At Hovione, PAT is applied for Chemical, Spray Drying and Drug Product processes.