Process analytical technologies (PAT) are the methods, tools and techniques used in industry to control critical parameters and monitor (bio)processes in real time. In the context of evolving regulatory environment and a shift towards quality by design (QbD), these tools are becoming increasingly crucial in every step of complex biologics production.
They include classical analytical instruments, online sensors, and data analysis algorithms, and make use of Infrared as well as Raman spectroscopy as they have the advantage of not requiring sampling. Through regular measures, unwanted events can be identified early in the process, and adjustments can be made to minimize deviations which could lead to batch segregation for non-conforming materials for example.