Abstract: Highly stable, pharmaceutical compositions comprising a therapeutically effective amount of a biologically active recombinant lipophilic protein such as human .beta.-interferon and interleukin-2 dissolved in a non-toxic, inert, therapeutically compatible aqueous-based carrier at pH ranges of from about 6.8 to 7.8 and about 8.5 to 10, which formulations contain a stabilizer for the protein selected from the group comprising human serum album, human serum albumin and dextrose or human plasma protein fraction, and at a pH range of from about 2 to 4, which latter formulations optionally contain a carbohydrate and/or protein stabilizer, are disclosed. Further, preferred formulation processes to prepare said compositions are described which avoid highly alkaline conditions.

Abstract: Stable pharmaceutical compositions suitable for parenteral administration to animals or humans are prepared comprising a therapeutically effective amount of a recombinant IFN-.beta. protein dissolved in an inert carrier medium comprising as solubilizer/stabilizer(s) one or more biocompatible non-ionic polymeric detergents or a combination of one or more biocompatible non-ionic polymeric detergents with an additional solubilizing and/or stabilizing agent, such as sodium dodecyl sulfate or glycerol. The compositions are in liquid form or lyophilized.

Abstract: Shipping fever, and other stress-related diseases in livestock, are treated by administration of a microencapsulated composition comprising IL-2 conjugated with a polyoxyethylene polymer, and mixed with a release-modulating amount of humen serum albumin. The microcapsules are administered parenterally, and release an effective amount of conjugated IL-2 continuously over a period of 14-30 days. These microcapsules are also effective in the treatment of cancer in mammals.

Abstract: An improved process for recovering and purifying lipophilic recombinant proteins such as human .beta.-interferon and interleukin-2 from their hosts yields a protein preparation which may be formulated into a stable pharmaceutical composition having a therapeutically effective amount of the biologically active recombinant lipophilic protein dissolved in a non-toxic, inert, therapeutically compatible aqueous-based carrier medium at a pH of 6.8 to 7.8 which medium also contains a stabilizer for the protein, such as human serum albumin, normal serum albumin and human plasma protein fraction.

Abstract: A sterile, stable lyophilized formulation of selectively oxidized microbially produced recombinant IL-2 in which the recombinant IL-2 is admixed with a water soluble carrier such as mannitol that provides bulk, and a sufficient amount of sodium dodecyl sulfate to ensure the solubility of the recombinant IL-2 in water. The formulation is suitable for reconstitution in aqueous injections for parenteral administration and it is stable and well tolerated in human patients. FIG. 1 illustrates a preferred method of purifying recombinant IL-2 suitable for use in preparing the formulations of the present invention.