More than 70 Years of Pyrogen Detection: Current State and Future Perspectives
| Autor: | Stefan Fennrich, Christian Schlensak, Hans Peter Wendel, Sandra Stoppelkamp, Leila Toliashvili, Ulrike Hennig |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
chemical and pharmacologic phenomena Animal Testing Alternatives Toxicology History 21st Century Monocytes General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Human health In vivo Horseshoe Crabs medicine Animals Humans Limulus Test biology Pyrogens Septic shock business.industry Amoebocyte lysate 030111 toxicology hemic and immune systems General Medicine History 20th Century medicine.disease biology.organism_classification Medical Laboratory Technology 030104 developmental biology Gene Expression Regulation Biological significance Animal Testing Alternative Limulus Immunology Rabbit test Cytokines Rabbits business |
| Zdroj: | Alternatives to Laboratory Animals. 44:239-253 |
| ISSN: | 2632-3559 0261-1929 |
| DOI: | 10.1177/026119291604400305 |
| Popis: | In the quality assurance of medical products, tests for sterility are essential. For parenteral pharmaceuticals, avoiding the presence of pyrogens is crucial. These fever-inducing substances (endotoxins and non-endotoxins) are not eliminated by standard sterilisation processes, and are biologically active once in the bloodstream, causing risks to human health, ranging from mild reactions (e.g. fever) to septic shock and death. Therefore, for injectable formulations, pyrogen testing is mandatory. Over the years, various pyrogen testing methods have been introduced, namely: in the 1940s, the rabbit pyrogen test, which is an in vivo test that measures the fever reaction as an endpoint; in the 1970s, the Limulus Amoebocyte Lysate (LAL) test, which is an in vitro test (with the haemolymph of the horseshoe crab) that specifically detects endotoxin; and in 2010, the Monocyte-Activation Test (MAT), which is a non-animal based in vitro pyrogen test that represents a full replacement of the rabbit test. Due to the ubiquity and biological significance of pyrogens, we are currently further developing the MAT so that it can be used for other applications. More specifically, our focus is on the detection of pyrogenic contamination on medical devices, as well as on the measurement of air quality. In addition, further improvements to permit the use of cryopreserved blood in the MAT, to overcome the limitations in the availability of freshly-drawn blood from human donors, are ongoing. |
| Databáze: | OpenAIRE |
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