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  • Title: Development and validation of a bioassay for interleukin-2.
    Author: Hammerling U, Henningsson AC, Sjödin L.
    Journal: J Pharm Biomed Anal; 1992 Aug; 10(8):547-53. PubMed ID: 1463788.
    Abstract:
    A reliable and precise method for the determination of IL-2 activity, based on stimulation of CTLL cell proliferation, was developed. Cells were incubated with different concentrations of IL-2 for 24 h in microtiter plates. The stimulatory effect was measured on a plate-reading spectrophotometer by reading the optical density of formazan, which is produced by viable cells from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT). The bioassay was designed as a four-dose parallel line test, fulfilling pharmacopoeial requirements for assay validity, and the inter-assay relative standard deviation (RSD) for a group of four experiments was 2.6%. The International Standard for human IL-2 and the Reference Reagent for Recombinant DNA-derived IL-2 were employed for potency determinations. The method was found suitable for potency assessments of pharmaceutical formulations of IL-2.
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