Recombinant human albumin as a stabilizer for biological materials and forthe preparation of international reference reagents

Recombinant human albumin expressed in Saccharomyces cerevisiae was compare d with native human serum albumin in its physicochemical properties and in its use as a stabilizer in lyophilized preparations of thyroid-stimulating hormone (TSH), interleukin 15 (IL-15) and granulocyte colony-stimulating fa ctor (G-CSF). Advantages of recombinant albumin include its lack of potenti al human contaminants and infectious agents. When used at concentrations of 0.1-0.2% (w/v), recombinant albumin was equivalent to native serum albumin in its capacity to protect immunological, biological and biochemical prope rties of TSH, IL-15 and G-CSF. Physicochemical characteristics of the two f orms of albumin including their binding to fatty acids were also similar. T he recombinant form of albumin used in this study should be considered as a suitable stabilizer in the preparation of lyophilized products and referen ce reagents. (C) 1998 The International Association of Biological Standardi zation.