Assay of pyrogens by interleukin-6 release from monocytic cell lines.
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.
Taktak
Y S
YS
Department of Endocrinology, National Institute for Biological Standards and Control, Potters Bar, Herts, UK.
Selkirk
S
S
Bristow
A F
AF
Carpenter
A
A
Ball
C
C
Rafferty
B
B
Poole
S
S
D000818:Animals; D002460:Cell Line; D004340:Drug Contamination; D004731:Endotoxins / Q000494:pharmacology; D004797:Enzyme-Linked Immunosorbent Assay; D015850:Interleukin-6 / Q000378:metabolism*; D009000:Monocytes / Q000187:drug effects / Q000378:metabolism*; D011749:Pyrogens / Q000032:analysis*; D011817:Rabbits; D011863:Radioimmunoassay
D004731:Endotoxins; D015850:Interleukin-6; D011749:Pyrogens