Process Analytical Technology

Overview

FDA-recognized framework for real-time in-process measurement and control of biopharmaceutical manufacturing quality, formally established in 2004 guidance; adoption remains slow despite available technology due to business case gaps and organizational risk aversion The FDA issued its Process Analytical Technology guidance in 2004, yet 22 years later inline process monitoring with closed-loop feedback control has still not been broadly adopted in commercial biomanufacturing, reflecting persistent organizational and regulatory barriers. The core business case for PAT is enabling product quality feedback control in the bioreactor and downstream: real-time measurement of critical quality attributes such as glycosylation allows compensation for raw material variability, reducing deviations and cutting development costs. (Segment 7 (30:00-35:00))