Unlocking The Power Of Process Analytical Technology (PAT): Elevating Downstream Process Development With Real-Time Data Monitoring

Improving process understanding and control is a top priority in today’s biopharmaceutical landscape—and for good reason. A stronger understanding of manufacturing processes can minimize variability, enhance root cause analysis, and guarantee safer therapies for patients. This approach is strongly supported by FDA guidelines, which promote the implementation of Quality by Design (QbD). This methodology emphasizes integrating quality into the early stages of the development process, rather than relying solely on end-point testing. A key enabler of this shift is Process Analytical Technology (PAT), which provides real-time, in-line, or on-line insights into critical process parameters (CPPs) and their impact on critical quality attributes (CQAs).

An advanced PAT approach utilizing mid-infrared (MIR) spectroscopy has been implemented to monitor both therapeutic proteins and excipients during downstream processes. By analyzing molecular fingerprints in real-time, this technology enhances process control, enables accurate concentration tracking, and significantly reduces development timelines.

Examine how real-time monitoring can enhance your process strategy and support both traditional and continuous manufacturing.