Since their initiation by the FDA in 2004, Process Analytical Technology (PAT) has been at the heart of the biopharmaceutical industry processes, allowing enhanced control and understanding of production operations. Through timely measurements of critical quality attributes (CQA) on-line, at-line and off-line, without disturbing the process, PAT enables real-time quality assurance. It encompasses a wide variety of techniques such as spectroscopy, chromatography as well as chemometrics. The ultimate goal of PAT is to reach a level of process control high enough to ensure the final product conformation and eventually real-time release testing (RTRT).
PAT techniques include classical analytical instruments, online sensors, and data analysis algorithms, and make use of Infrared as well as Raman spectroscopy. Used on-line in fermentations such as perfusion cell culture, it predicts various media components which have an impact on product quality.
Read here how we use PAT to improve bioprocesses: