Some factors affecting the stability of interferon alpha 2b in solution.
In this paper we evaluated the influence of the protein concentration and a formulation vehicle on the stability of recombinant human Interferon alpha 2b (rhIFN-alpha2b) in solution. The effect of the protein content (from 1 to 100 MIU/ml) at 37 degrees C, showed that higher concentration of this cytokine protected against the loss of bioactivity (antiviral titration) better than the lower concentrations. In contrast, rhIFN-alpha2b at 50 and 100 MIU/ml decreased the SDS/PAGE- and RP-HPLC-determined purity faster than samples at 1 or 10 MIU/ml. According to these results, 10 MIU/ml rhIFN-alpha2b was the best choice to evaluate the influence of a formulation on the stability of this cytokine. Taking this into consideration, we studied the stability of a liquid and albumin-free formulation of this protein at the recommended storage temperature (5+/-3 degrees C) and under accelerated conditions (28+/-2 degrees C). Accelerated storage results showed an acceptable biochemical stability of the active ingredient throughout 2 months. Real-time storage data confirmed the good biochemical stability of this formulation for 30 months.
Ruiz
Llamil
L
Center for Genetic Engineering and Biotechnology (CIGB), Formulation Development Department, P.O. Box 6162, Havana, Cuba. llamil.ruiz@cigb.edu.cu
Reyes
Nuria
N
Aroche
Kethia
K
Báez
Reynier
R
Aldana
Raymersy
R
Hardy
Eugenio
E
D000418:Albumins / Q000737:chemistry; D000998:Antiviral Agents / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000737:chemistry*; D011994:Recombinant Proteins; D012996:Solutions / Q000737:chemistry; D013696:Temperature
D000418:Albumins; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012996:Solutions