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Raman spectroscopy as a process analytical technology to investigate biopharmaceutical freeze concentration processes

Weber, Dennis 1; Hubbuch, Jürgen ORCID iD icon 1
1 Institut für Bio- und Lebensmitteltechnik (BLT), Karlsruher Institut für Technologie (KIT)


Freezing processes are a well-established unit operation in the biopharmaceutical industry to increase the shelf-life of protein-based drugs. While freezing reduces degradation reaction rates, it may also exert stresses such as freeze concentration. Macroscopic freeze concentration in large-scale freezing processes has been described thoroughly by examination of frozen bulk material, but the transient process leading to such freeze concentration profiles has not been monitored yet for biopharmaceutical solutions. In this study, Raman spectroscopy as a process analytical technology is demonstrated for model formulations containing monoclonal antibodies (mAbs) or bovine serum albumin (BSA) in varying concentrations of sucrose and buffer salts. Therefore, a Raman probe was immersed into a bulk volume at different heights, monitoring the freeze concentration in the liquid phase during the freezing processes. Partial least square regression models were used to quantitatively discriminate between the protein and excipients simultaneously. The freeze concentration profiles were dependend on freezing temperature and formulation with freeze concentrations up to 2.4-fold. ... mehr

Verlagsausgabe §
DOI: 10.5445/IR/1000138414
Veröffentlicht am 01.10.2021
DOI: 10.1002/bit.27936
Zitationen: 2
Web of Science
Zitationen: 1
Zitationen: 2
Cover der Publikation
Zugehörige Institution(en) am KIT Institut für Bio- und Lebensmitteltechnik (BLT)
Publikationstyp Zeitschriftenaufsatz
Publikationsmonat/-jahr 12.2021
Sprache Englisch
Identifikator ISSN: 0006-3592, 1097-0290
KITopen-ID: 1000138414
Erschienen in Biotechnology & bioengineering
Verlag John Wiley and Sons
Band 118
Heft 12
Seiten 4708-4719
Vorab online veröffentlicht am 18.09.2021
Nachgewiesen in Dimensions
Web of Science
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