ABSTRACT
The advent of the recombinant DNA revolution now makes it possible to prepare these proteins in large amounts and at reasonable cost. Human leukocyte interferon represents one of the most prominent recombinant protein products of the biotechnology era to have gone through comprehensive clinical trials. In humans there are numerous subtypes of α-interferon and scientists at Hoffmann-La Roche have produced recombinant human leukocyte interferon α-2α (rIFNα-2α) for clinical use. The successful cloning in Escherichia coli of human leukocyte interferon was a collaborative effort by scientists at Genentech and Hoffmann-La Roche. The chapter presents a description of the process used for the purification of clinical quality rIFNα-2α. It has adopted immunoaffinity chromatography as the first purification step. The ion-exchange chromatography step is to remove the nonionic detergents, which had been used in the preceding chromatography steps. The Permeation Chromatography step is to remove small amounts of contaminating oligomeric rIFNα-2α, as well as high-molecular weight endotoxins.
