| Autor: |
G C, Visor, K P, Tsai, M D, Miller, J, Duffy, T, Calderwood, D, Lokensgard, J, Killian, T, Malefyt, L, Gu, I, Massey |
| Rok vydání: |
1990 |
| Předmět: |
|
| Zdroj: |
Lymphokine research. 9(3) |
| ISSN: |
0277-6766 |
| Popis: |
The development and characterization of a lyophilized dosage form for recombinant Interleukin-1 beta is described. Included in the evaluation of the drug product are accelerated and long-term stability studies utilizing a number of biophysical techniques (reverse-phase HPLC, SDS-PAGE, isoelectric focusing and ELISA). Data collected with these methods were examined for correlations with biological activity assessments provided by an in-vitro cell culture system (mouse thymocyte proliferation). Results of these studies demonstrate that a lyophilized dosage form of Interleukin-1 beta can be prepared which retains its potency for at least 1 year when stored at ambient temperature. The analytical methodology used to assess the physicochemical integrity of the protein provided a sensitive and reproducible means of predicting changes in biological activity. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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