In vitro pyrogen test for toxic or immunomodulatory drugs

Mardas Daneshian, Armin Guenther, Albrecht Wendel, Thomas Hartung, Sonja von Aulock

Research output: Contribution to journalArticle

Abstract

Pyrogenic contaminations of some classes of injectable drugs, e.g. toxic or immunomodulatory as well as false-positive drugs, represent a major risk which cannot yet be excluded due to the limitations of current tests. Here we describe a modification of the In vitro Pyrogen Test termed AWIPT (Adsorb, Wash, In vitro Pyrogen Test), which addresses this problem by introducing a pre-incubation step in which pyrogenic contaminations in the test sample are adsorbed to albumin-coated beads. After rinsing, the beads are incubated with human whole blood and the release of the endogenous pyrogen interleukin-1β is measured as a marker of pyrogenic activity. Intentional contaminations with lipopolysaccharide were retrieved from the chemotherapeutic agents paclitaxel, cisplatin and liposomal daunorubicin, the antibiotic gentamicin, the antifungal agent liposomal amphotericin B, and the corticosteroid prednisolone at lower dilutions than in the standard in vitro pyrogen test. This represents a promising new approach for the detection of pyrogenic contamination in drugs or in drugs containing interfering additives and should lead to improved safety levels.

Original languageEnglish (US)
Pages (from-to)169-175
Number of pages7
JournalJournal of Immunological Methods
Volume313
Issue number1-2
DOIs
StatePublished - Jun 30 2006
Externally publishedYes

    Fingerprint

Keywords

  • Interleukin-1β
  • Lipopolysaccharide
  • Pyrogen testing
  • Whole blood test

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this