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J Pharm Pharmacol. 1991 Aug;43(8):578-82.

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

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1
Department of Endocrinology, National Institute for Biological Standards and Control, Potters Bar, Herts, UK.

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.

[Indexed for MEDLINE]

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