Approaches to the stabilization of interferons.

Considerable effort has been expended in the past few years toward establishing an armamentarium of different techniques to stabilize naturally produced alpha-and beta-interferons, particularly the beta type in view of its greater lability. Of the techniques reported, it seems that addition of various proteins, rare earth salts, and use of acid pH conditions may be the most useful since they are relatively nontoxic and protect against both thermal and mechanical stress inactivation. Little has so far been reported on the stability of recombinant DNA-derived interferons. It is unlikely that they will be any more stable when they are purified than the natural human interferons. To generate stable preparations of these bacteria-produced interferons for clinical use it is important to establish different nontoxic techniques and approaches to prevent inactivation of these interferons during preparation, processing, concentration, purification and storage.