An alternative sterility assessment for parenteral drug products using isothermal microcalorimetry
| Autor: | Stephan Krähenbühl, Ulrich Zuber, David Brueckner, Gernot Bonkat, Olivier Braissant |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Drug Isothermal microcalorimetry Sterility Sterility testing media_common.quotation_subject 030106 microbiology Calorimetry Pharmacology Biology Applied Microbiology and Biotechnology 03 medical and health sciences Sterility test media_common Alternative methods Study drug business.industry Reproducibility of Results General Medicine Biotechnology 030104 developmental biology Pharmaceutical Preparations Infertility Drug production Drug Contamination business Filtration |
| Zdroj: | Journal of Applied Microbiology. 123:773-779 |
| ISSN: | 1364-5072 |
| Popis: | Aims 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. Methods and Results 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. Conclusions 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. Significance and Impact of the Study 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text