83] Procedures for stabilization of interferons

Abstract

Publisher Summary This chapter discusses the procedures for stabilization of interferons. The stability of interferons, especially as they are processed and purified, has proved to be a greater problem than is appreciated from early observations on the stability of crude materials. It is now realized that interferons in solution can be inactivated by a variety of physical and chemical treatments, but a degree of stability can be provided by means of certain additives. For long-term storage of interferon preparations, particularly those intended for clinical use, freeze-drying is preferred. One of the most effective methods of preserving interferon activity for extended periods, such as storage of reference reagents or preparations for clinical use, is freeze-drying in the presence of low concentrations of added protein and a sodium phosphate buffer. Two accelerated storage tests are used to predict the stability of freeze-dried interferons. The accelerated multiple isothermal stability test is used to provide a conservative estimate of the expected stability of these standards under long-term storage conditions.