title: Spectroscopic sensors for in-line bioprocess monitoring in research and pharmaceutical industrial application.
abstract: The use of spectroscopic sensors for bioprocess monitoring is a powerful tool within the process analytical technology (PAT) initiative of the US Food and Drug Administration. Spectroscopic sensors enable the simultaneous real-time bioprocess monitoring of various critical process parameters including biological, chemical, and physical variables during the entire biotechnological production process. This potential can be realized through the combination of spectroscopic measurements (UV/Vis spectroscopy, IR spectroscopy, fluorescence spectroscopy, and Raman spectroscopy) with multivariate data analysis to obtain relevant process information out of an enormous amount of data. This review summarizes the newest results from science and industry after the establishment of the PAT initiative and gives a critical overview of the most common in-line spectroscopic techniques. Examples are provided of the wide range of possible applications in upstream processing and downstream processing of spectroscopic sensors for real-time monitoring to optimize productivity and ensure product quality in the pharmaceutical industry.
authors.affiliation: Institute of Technical Chemistry, Gottfried Wilhelm Leibniz University of Hannover, Callinstraße 5, 30167, Hannover, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Claßen
authors.affiliation: Institute of Technical Chemistry, Gottfried Wilhelm Leibniz University of Hannover, Callinstraße 5, 30167, Hannover, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Aupert
authors.affiliation: Department of Chemical Biological Engineering, Colorado State University, 344 Scott Bioengineering, Fort Collins, Colorado, 80523-1370, USA.
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Reardon
authors.affiliation: Institute of Technical Chemistry, Gottfried Wilhelm Leibniz University of Hannover, Callinstraße 5, 30167, Hannover, Germany. solle@iftc.uni-hannover.de.
authors.forename: Dörte
authors.initials: D
authors.lastname: Solle
authors.affiliation: Institute of Technical Chemistry, Gottfried Wilhelm Leibniz University of Hannover, Callinstraße 5, 30167, Hannover, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Scheper
mesh_terms: D015374:Biosensing Techniques / Q000295:instrumentation; D001709:Biotechnology / Q000295:instrumentation*; D013059:Spectrum Analysis, Raman / Q000295:instrumentation*; D013678:Technology, Pharmaceutical / Q000295:instrumentation*
keywords: Bioprocess monitoring; Critical process parameters; In-line monitoring; Process analytical technology; Spectroscopic sensors