The Long-Term Stability of Recombinant (Serine-17) Human Interferon-β

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Abstract
Escherichia coli-derived (Serine 17) human interferon-β (HuIFN-βSER) as formulated with SDS and placed at multiple isothermal temperatures (-70°C to 37°C). Three stability-indicating test methods (bioassay, SDS-PAGE, RP-HPLC) were used to evaluate the long-term stability of this preparation. No change was observed when stored for nearly a year at either -70°C or 4°C. At the elevated temperatures, proteolytic cleavage, noncovalent oligomer formation, and loss of antiviral activity were observed. The absence of a carrier protein makes this stable IFN-β frozen reference preparation useful as a standard in both biological assays and protein chemical methods of analysis.