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Flexible automation with compact NMR spectroscopy for continuous production of pharmaceuticals

  • Modular plants using intensified continuous processes represent an appealing concept for the production of pharmaceuticals. It can improve quality, safety, sustainability, and profitability compared to batch processes; besides, it enables plug-and-produce reconfiguration for fast product changes. To facilitate this flexibility by real-time quality control, we developed a solution that can be adapted quickly to new processes and is based on a compact nuclear magnetic resonance (NMR) spectrometer. The NMR sensor is a benchtop device enhanced to the requirements of automated chemical production including robust evaluation of sensor data. Beyond monitoring the product quality, online NMR data was used in a new iterative optimization approach to maximize the plant profit and served as a reliable reference for the calibration of a near-infrared (NIR) spectrometer. The overall approach was demonstrated on a commercial-scale pilot plant using a metal-organic reaction with pharmaceuticalModular plants using intensified continuous processes represent an appealing concept for the production of pharmaceuticals. It can improve quality, safety, sustainability, and profitability compared to batch processes; besides, it enables plug-and-produce reconfiguration for fast product changes. To facilitate this flexibility by real-time quality control, we developed a solution that can be adapted quickly to new processes and is based on a compact nuclear magnetic resonance (NMR) spectrometer. The NMR sensor is a benchtop device enhanced to the requirements of automated chemical production including robust evaluation of sensor data. Beyond monitoring the product quality, online NMR data was used in a new iterative optimization approach to maximize the plant profit and served as a reliable reference for the calibration of a near-infrared (NIR) spectrometer. The overall approach was demonstrated on a commercial-scale pilot plant using a metal-organic reaction with pharmaceutical relevance.zeige mehrzeige weniger

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Metadaten
Autoren/innen:Simon KernORCiD, Lukas WanderORCiD, Klas MeyerORCiD, Svetlana Guhl, A. R. Gottu Mukkula, M. Holtkamp, M. Salge, C. Fleischer, N. Weber, S. Engell, Andrea PaulORCiD, M. Pereira Remelhe, Michael MaiwaldORCiD
Dokumenttyp:Zeitschriftenartikel
Veröffentlichungsform:Verlagsliteratur
Sprache:Englisch
Titel des übergeordneten Werkes (Englisch):Analytical and Bioanalytical Chemistry
Jahr der Erstveröffentlichung:2019
Organisationseinheit der BAM:1 Analytische Chemie; Referenzmaterialien
1 Analytische Chemie; Referenzmaterialien / 1.4 Prozessanalytik
Veröffentlichende Institution:Bundesanstalt für Materialforschung und -prüfung (BAM)
Verlag:Springer Nature
Verlagsort:Heidelberg
Jahrgang/Band:411
Ausgabe/Heft:14
Erste Seite:3037
Letzte Seite:3046
DDC-Klassifikation:Naturwissenschaften und Mathematik / Chemie / Analytische Chemie
Freie Schlagwörter:CONSENS; Continuous processes; Data Fusion; NIR Spectroscopy; NMR Spectroscopy; Real-time process monitoring; Real-time quality control
Themenfelder/Aktivitätsfelder der BAM:Analytical Sciences
Analytical Sciences / Spurenanalytik und chemische Zusammensetzung
Analytical Sciences / Sensorik
DOI:https://doi.org/10.1007/s00216-019-01752-y
URN:urn:nbn:de:kobv:b43-480623
URL:http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=Alerting&SrcApp=Alerting&DestApp=MEDLINE&DestLinkType=FullRecord&UT=MEDLINE:30903225
ISSN:1618-2642
ISSN:1618-2650
Bemerkung:
Link to original data:
https://dx.doi.org/10.5281/zenodo.1438233
Verfügbarkeit des Dokuments:Datei für die Öffentlichkeit verfügbar ("Open Access")
Lizenz (Deutsch):License LogoCreative Commons - CC BY - Namensnennung 4.0 International
Datum der Freischaltung:27.05.2019
Referierte Publikation:Ja
Datum der Eintragung als referierte Publikation:27.05.2019
Schriftenreihen ohne Nummerierung:Wissenschaftliche Artikel der BAM