Eine wirklich humane Bestimmung von Endotoxinen und Nicht-Endotoxin- Pyrogenen

Translated title of the contribution: A truely human(e) determination of endotoxins and non-endotoxin pyrogens

Thomas Hartung, Nina Hasiwa, Mardas Daneshian, Bodo Holtkamp, Gabriele Schmitz, Anke Hossfeld

Research output: Contribution to journalArticlepeer-review

Abstract

Pyrogen testing as a crucial safety test for many drugs and medical devices was traditionally performed in the rabbit or limulus (LAL) test. Following international validation and acceptance of novel monocyte activation tests (MAT) based on the human fever reaction in Europe and the US, a number of limitations of these assays could be overcome. Increasingly, they replace the still 110 000 rabbits used in Europe for pyrogen testing. In contrast to the LAL they detect non-endotoxin pyrogens. The variant of MAT presented here based on (cryopreserved) whole blood has found the broadest application because of its simplicity, standardization as internationally available kit, and the advantage to be able to bring the cell suspension also in direct contact with solid materials. The development, validation and the steadily expanding use of the method is described. For animal welfare reasons, it is today difficult to justify carrying still out a rabbit pyrogen test. Whenever non-endotoxin pyrogens or the potency of the given endotoxin in humans matters, the test has also clear advantages over the LAL.

Translated title of the contributionA truely human(e) determination of endotoxins and non-endotoxin pyrogens
Original languageGerman
Pages (from-to)825-834
Number of pages10
JournalPharmazeutische Industrie
Volume75
Issue number5
StatePublished - Jul 19 2013

Keywords

  • Alternativen zu Tierversuchen
  • Chargenprüfung
  • Fieber
  • Mikrobiologische Sicherheit
  • Pyrogen-Testung
  • Verunreinigungen

ASJC Scopus subject areas

  • Pharmaceutical Science

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