Exploiting Fluorescent Reporter Molecules for Process Analytical Technology (PAT)

FH – HES

Abstract

Process Analytical Technology (PAT) launched by the U.S. Food and Drug Administration (FDA) aims to ensure the quality of pharmaceutical products. One important tool to obtain a deeper process understanding is the use of modern real-time process sensors and analyzers. In this context an industrially accepted optical probe for turbidity measurement (Aquasant probe) has been adapted for on-line and real-time fluorescence measurement in (bio-)reactors. By tagging product proteins with fluorescent reporter molecules (e.g. GFP) it was possible to quantify product concentrations during a fermentation process with the new probe. The on-line obtained signal showed a high correlation to the off-line signal. This new method has remarkable advantages compared to classical off-line product lab analyses and can serve as a platform-independent quantification method of products to be used in either up- or downstream processing.