Parameters for the evaluation of long-term stability of tumour necrosis factor preparations.
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.
Geigert
J
J
Cetus Corporation, Emeryville, CA 94608.
Panschar
B M
BM
Taforo
C
C
Paola
J
J
Fong
S
S
Huston
H N
HN
Wong
D E
DE
Wong
D Y
DY
D000595:Amino Acid Sequence; D000818:Animals; D002470:Cell Survival / Q000187:drug effects; D002872:Chromosome Deletion; D004355:Drug Stability; D005796:Genes; D051379:Mice; D009154:Mutation; D011786:Quality Control; D011994:Recombinant Proteins / Q000494:pharmacology / Q000592:standards*; D012996:Solutions; D013696:Temperature; D013997:Time Factors; D014409:Tumor Necrosis Factor-alpha / Q000235:genetics / Q000494:pharmacology / Q000592:standards*
D011994:Recombinant Proteins; D012996:Solutions; D014409:Tumor Necrosis Factor-alpha