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Development and validation of a bioassay for interleukin-2
U Hammerling1, A C Henningsson, L Sjödin
1Pharmacological Division, Medical Products Agency, Uppsala, Sweden.
Journal of Pharmaceutical and Biomedical Analysis
|August 1, 1992
Summary
A new bioassay accurately measures Interleukin-2 (IL-2) activity by assessing CTLL cell proliferation using the MTT assay. This reliable method is suitable for pharmaceutical IL-2 potency testing.
Area of Science:
- Biotechnology
- Immunology
- Pharmacology
Background:
- Interleukin-2 (IL-2) is crucial for immune responses.
- Accurate IL-2 activity determination is vital for therapeutic applications.
- Existing methods may lack precision for pharmaceutical formulations.
Purpose of the Study:
- To develop a reliable and precise bioassay for quantifying IL-2 activity.
- To validate the assay for use with pharmaceutical IL-2 formulations.
- To establish a method meeting pharmacopoeial standards for bioassays.
Main Methods:
- Utilized CTLL cell proliferation as a readout for IL-2 stimulation.
- Employed the MTT assay to measure viable cell metabolic activity.
- Designed the bioassay as a four-dose parallel line test.
- Used the International Standard for human IL-2 for calibration.
Main Results:
- The bioassay demonstrated high precision with an inter-assay relative standard deviation (RSD) of 2.6%.
- The method successfully measured IL-2 activity across different concentrations.
- The assay design met pharmacopoeial requirements for validity.
Conclusions:
- A robust and precise bioassay for IL-2 activity determination was successfully developed.
- The method is suitable for potency assessments of pharmaceutical IL-2 products.
- This assay provides a reliable tool for quality control in IL-2 manufacturing.