Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood

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2009
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Alternatives to Animal Experimentation : ALTEX. 2009, 26(4), pp. 265-277. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.2009.4.265
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Microorganisms such as Gram-negative or Gram-positive bacteria, viruses and fungi contain components that activate the innate immune system. These components, called pyrogens (Greek: pyros=fire), can occur independently of viable microorganisms and are a major safety concern in parenterally administered drugs, since they can cause severe reactions such as fever, organ failure, and shock in the recipient. So far these drugs have been tested by injecting them intravenously into rabbits and measuring their fever reaction or, alternatively, by the Limulus Amoebocyte Lysate (LAL) test, employing the coagulation of the hemolymph lysate of Limulus polyphemus. Both tests have inherent limitations. A new in vitro monocyte activation test (MAT) based on human whole blood, capable of measuring all pyrogens relevant to the human patient, introduced in this journal in 1995, was validated and recently accepted by European Pharmacopoeia and US FDA. This review describes its principle, development, validation and the wide spectrum of applications, such as for testing of medical devices, blood products, toxic or immunomodulatory drugs, dialysis liquids, lipidic parenterals, and air quality. This alternative method promises to replace the rabbit pyrogen test fully and to overcome several limitations of the LAL assay.

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570 Biowissenschaften, Biologie
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ISO 690SCHINDLER, Stefanie, Sonja von AULOCK, Mardas DANESHIAN, Thomas HARTUNG, 2009. Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood. In: Alternatives to Animal Experimentation : ALTEX. 2009, 26(4), pp. 265-277. ISSN 1868-596X. eISSN 1868-8551. Available under: doi: 10.14573/altex.2009.4.265
BibTex
@article{Schindler2009Devel-38603,
  year={2009},
  doi={10.14573/altex.2009.4.265},
  title={Development, validation and applications of the monocyte activation test for pyrogens based on human whole blood},
  number={4},
  volume={26},
  issn={1868-596X},
  journal={Alternatives to Animal Experimentation : ALTEX},
  pages={265--277},
  author={Schindler, Stefanie and Aulock, Sonja von and Daneshian, Mardas and Hartung, Thomas}
}
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