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The international standard for human interleukin-2. Calibration by international collaborative study
1Division of Immunobiology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, U.K.
Journal of Immunological Methods
|November 10, 1988
Summary
Three interleukin-2 (IL-2) preparations were evaluated. Preparation 86/504 demonstrated excellent stability and performance, leading to its establishment as the 1st international standard for IL-2.
Area of Science:
- Immunology
- Biotechnology
- Biologics Standardization
Background:
- Interleukin-2 (IL-2) is a critical cytokine for immune responses.
- Accurate quantification and standardization of IL-2 are essential for research and therapeutic applications.
- Existing reference materials require validation for international use.
Purpose of the Study:
- To evaluate three lyophilized interleukin-2 (IL-2) preparations for their suitability as an international standard.
- To assess the stability and performance of candidate IL-2 standards across various bioassay systems.
- To establish an official international standard for IL-2.
Main Methods:
- International collaborative study involving multiple bioassay systems.
- Accelerated temperature degradation studies to assess stability.
- Evaluation of lyophilized IL-2 preparations coded 86/500, 86/564, and 86/504.
Main Results:
- All three IL-2 preparations performed well in diverse bioassay systems.
- Excellent stability was observed for all preparations under accelerated degradation conditions.
- Preparation 86/504, similar to an existing interim reagent, showed high suitability.
Conclusions:
- Preparation 86/504 was established as the 1st international standard for interleukin-2 in 1987.
- The standard has a defined potency of 100 IU/ampoule.
- This standardization facilitates consistent IL-2 measurement globally.