Overview
The active ingredients of biopharmaceuticals often have complex and unstable molecular structures compared with chemical synthetic drugs, and quality control is particularly important. In 2004, the U.S. FDA proposed monitoring of the manufacturing process of pharmaceuticals using PAT: Process Analytical Technology (Process Analytical Technique) in order to improve the quality assurance of pharmaceuticals (Ref. 1, 2).
We have developed two types of in-line sensor systems using our long-cultivated near-infrared spectroscopy techniques and a mathematical model software technique to achieve real-time monitoring of glucose and lactate and live cell density. This application note presents the characteristics of these in-line sensor systems and the results of their monitoring in CHO cell cultures.
※1:FDA, Pharmaceutical cGMPs for the 21st century - A risk-based approach; Final Report, (September 2004).
※2:FDA, Guidance for industry:PAT - A framework for innovative pharmaceutical development, manufacturing and quality assurance, (September 2004).