Potency stability of recombinant (Serine-17) human interferon-beta

Area of Science:

• Biochemistry
• Pharmacology
• Biotechnology

Background:

• Recombinant human interferon-beta (Serine-17) produced in E. coli is a therapeutic protein.
• Formulation excipients are critical for maintaining protein stability and shelf-life.
• Human serum albumin is a common excipient used in biologic formulations.

Purpose of the Study:

• To evaluate the long-term stability of lyophilized recombinant human interferon-beta formulated with human serum albumin.
• To investigate the impact of human serum albumin concentration on the thermal stability of the interferon-beta formulation.
• To characterize the degradation kinetics of the biologic drug under various temperature conditions.

Main Methods:

• Lyophilized interferon-beta formulations with varying concentrations of human serum albumin were prepared.
• Antiviral activity was assessed using bioassays after storage under refrigeration for up to two years.
• Thermal stability was evaluated using isothermal and nonisothermal stress studies at elevated temperatures (25-80°C).
• Arrhenius kinetics were applied to model the stability data.

Main Results:

• The lyophilized interferon-beta formulation demonstrated stable antiviral activity for two years when stored under refrigeration.
• The stability of antiviral activity followed an Arrhenius model across tested temperatures.
• Increased concentrations of human serum albumin significantly enhanced the thermal stability of the formulation.

Conclusions:

• Lyophilization and refrigeration provide a stable storage condition for recombinant human interferon-beta for at least two years.
• Human serum albumin acts as a critical stabilizing excipient, improving the thermal resistance of the interferon-beta formulation.
• The findings support the use of human serum albumin for enhancing the shelf-life and handling conditions of biologic drugs like interferon-beta.