Real-time monitoring of CHO cell cultures with dual inline sensors

Download (628 KB)

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).

Related Products & Solutions

Advanced Control Bioreactor System BR1000

The Advanced Control Bioreactor System BR1000 automates lab-scale mammalian cell culture with highly accurate real-time monitoring and advanced process control.

Solutions for Cell-Based Manufacturing

Yokogawa's in-line sensors and advanced control algorithms will stabilize and improve the efficiency of the cell culture processes for biopharmaceutical production.


Have Questions?

Contact a Yokogawa Expert to learn how we can help you solve your challenges.