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An alternative sterility assessment for parenteral drug products using isothermal microcalorimetry

Brueckner, David and Krähenbühl, Stephan and Zuber, Ulrich and Bonkat, Gernot and Braissant, Olivier. (2017) An alternative sterility assessment for parenteral drug products using isothermal microcalorimetry. Journal of Applied Microbiology, 123 (3). pp. 773-779.

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Official URL: https://edoc.unibas.ch/59258/

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Abstract

Production and release of injectable drug solutions are highly regulated since the administration of injectables bypasses natural body barriers. The sterility test is the last opportunity of product quality assessment. However, sterility is currently assessed by visual inspection (VI) that is time consuming and somewhat subjective. Therefore, we assessed isothermal microcalorimetry (IMC) as a replacement for the VI of the filtration based state-of-the-art sterility control.; We used ATCC strains and house isolates to artificially contaminate frequently produced monoclonal antibodies (Avastin, Mabthera, Herceptin). After filtration, growth was assessed with IMC. Growth of all micro-organisms was reliably and reproducibly detected 4 days after inoculation, which was significantly faster than with VI.; The reliability and the sensitivity of IMC have a large potential to improve sterility controls. Further evaluation of this alternative method is therefore highly recommended.; Drug safety is of great concern for public health. Faster and safer drug production could be achieved using the technique described here. All the tests were performed with real manufactured drugs and complied with pharmaceutical standards. This suggests that drug sterility testing can be improved with potentially increased safety and cost reduction.
Faculties and Departments:03 Faculty of Medicine
03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmakologie (Krähenbühl)
UniBasel Contributors:Krähenbühl, Stephan
Item Type:Article, refereed
Article Subtype:Research Article
ISSN:1364-5072
e-ISSN:1365-2672
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:23 May 2020 11:52
Deposited On:23 May 2020 11:52

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