PAT: Build Quality into Biopharmaceutical Process

with Real-Time Monitoring and Control

HomeIntegrated OfferingsBiopharma 4.0Process Analytical Technology (PAT)


Process Analytical Technology (PAT) ensures quality in biopharmaceutical manufacturing by monitoring and controlling processes in real-time. It utilizes analytical tools to develop manufacturing processes that accommodate material and equipment variability. Once critical process parameters (CPPs) impacting critical quality attributes (CQAs) are identified, analytical methods are employed to monitor and control CPPs, maintaining them within the desired design space. This approach integrates quality by design (QbD) principles into the process rather than relying on product testing only in the end.

PAT: Build Quality into Biopharmaceutical Processes with Real-Time Monitoring and Control

Scientist using Process Analytical Technology tools in a lab.

PAT Enables the Facility of the Future

Incorporation of PAT into the manufacturing process helps establish the foundation for “bioprocessing 4.0” and the Facility of the Future, which is a complete digital transformation of pharmaceutical production using real-time monitoring, control systems, and data analytics. With PAT, real-time process monitoring is enabled, providing greater process understanding, agility, flexibility, and improved quality assurance.

Analytical Insights Improve Process Understanding and Product Quality

More recently, PAT typically involves the use of chromatographic, spectroscopic and/or mass spectrometric sensors that are integrated into upstream and downstream unit operations. These technologies are used in-line, on-line, or at-line to enable real-time monitoring and control of the process. By providing real-time insights, these sensors enable timely adjustments, optimization, and intervention, ultimately leading to improved process understanding and product quality.

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Related Resources

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