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Parameters for the evaluation of long-term stability of tumour necrosis factor preparations
J Geigert1, B M Panschar, C Taforo
1Cetus Corporation, Emeryville, CA 94608.
Developments in Biological Standardization
|January 1, 1988
Abstract:
Escherichia coli-derived Tumour Necrosis Factor (TNF) was formulated in the absence of a protein-carrier, both as a solution and as a lyophilized preparation. By means of three stability-indicating test methods (bioassay, SDS-PAGE, IEF), the long-term stability of these TNF preparations was evaluated. Both preparations showed no change upon storage for 9 months at -70 degrees C and -20 degrees C. Depending upon the test method, different rates of change were detected at elevated temperature. The analysis presented will assist in the design of future TNF reference standards.