Parameters for the evaluation of IL-2 stability.
Recombinant DNA derived interleukin-2 stability in accelerated and long term studies was evaluated using biological and protein chemical methods. Various biophysical parameters were investigated for their correlation with bioassay results and for their accuracy and utility as quantitative indicators of change. Biochemically distinguishable forms of the molecule exhibited different levels of IL-2 activity in vitro. Of the methods evaluated, SDS-PAGE and, to a greater extent, reverse phase and TSK based HPLC analyses have been found to measure relevant changes in the structure of human interleukin-2. Those test systems detect covalent and non-covalent aggregates, degradation products, and inappropriately oxidized forms of human interleukin-2 all of which contribute to an overall loss of IL-2 biological activity. Such measures provide sensitive and reproducible indications of changes relative to the standard bioassay. These studies have led to the development of an analog of interleukin-2 which is biologically active and shows improved long term stability.
D001681:Biological Assay; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004591:Electrophoresis, Polyacrylamide Gel; D006801:Humans; D007376:Interleukin-2 / Q000032:analysis
D007376:Interleukin-2