Assay of pyrogens by interleukin-6 release from monocytic cell lines

J Pharm Pharmacol. 1991 Aug;43(8):578-82. doi: 10.1111/j.2042-7158.1991.tb03540.x.

Abstract

A novel in-vitro system has been developed for the detection and quantification of pyrogen in pharmaceutical products. The measured variable was evoked secretion of the pyrogenic cytokine interleukin-6 from MONO MAC 6 monocytic cells incubated with the product. The interleukin-6 was detected using a specific and sensitive ELISA developed for this purpose. The test system detected pyrogenic contamination in 3 batches of therapeutic human serum albumin which had caused adverse reactions in recipients. The contamination was not detected in conventional tests: the rabbit pyrogen test and the limulus amoebocyte lysate test.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Cell Line
  • Drug Contamination*
  • Endotoxins / pharmacology
  • Enzyme-Linked Immunosorbent Assay
  • Interleukin-6 / metabolism*
  • Monocytes / drug effects
  • Monocytes / metabolism*
  • Pyrogens / analysis*
  • Rabbits
  • Radioimmunoassay

Substances

  • Endotoxins
  • Interleukin-6
  • Pyrogens