Process Analytical Technology (PAT): Advancing Pharmaceutical Manufacturing through Real-Time Process Control and Quality by Design Kumar Jeetendra | August 6, 2025 In the pharmaceutical industry, ensuring product quality and safety is paramount. Process Analytical Technology (PAT), a methodology defined by the U.S. FDA, has become an essential approach to designing, analyzing, and controlling manufacturing processes. By focusing on the measurement of critical process parameters (CPPs) that affect the quality of Active Pharmaceutical Ingredients (APIs), PAT ensures …
Pharmaceutical Quality by Design for Single-Use Components Kumar Jeetendra | August 8, 2026 The he last two decades have seen major changes in the biopharmaceutical industry. The importance of single-use systems (SUS) has grown from being specialty tools in a lab to critical infrastructures in the development and large-scale production of vaccines and biologics. Bioprocessing Components Can No Longer Be Treated as Commodity Plastics A modern-day bioprocess can …
