The long-term stability of recombinant (serine-17) human interferon-beta.
Escherichia coli-derived (Serine 17) human interferon-beta (HuIFN-beta SER) was formulated with SDS and placed at multiple isothermal temperatures (-70 degrees C to 37 degrees 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 degrees C or 4 degrees 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-beta frozen reference preparation useful as a standard in both biological assays and protein chemical methods of analysis.
Geigert
J
J
Department of Product Evaluation, Cetus Corporation, Emeryville, CA 94608.
Panschar
B M
BM
Fong
S
S
Huston
H N
HN
Wong
D E
DE
Wong
D Y
DY
Taforo
C
C
Pemberton
M
M
D001681:Biological Assay; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004591:Electrophoresis, Polyacrylamide Gel; D006801:Humans; D007370:Interferon Type I; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta; D011994:Recombinant Proteins
D007370:Interferon Type I; D011994:Recombinant Proteins; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000068556:Interferon beta-1a