Cetus Corporation

Cutter Laboratories, Inc.

Miles Laboratories, Inc.

Peter M Fernandes

John L Lundblad

Wolfgang H Hanisch

Kirston E Koths

Robert F Halenbeck

Terrance A Taforo

Willis L Warner

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.

Formulation for lipophilic IL-2 proteins

Compositions containing thermally sensitive, therapeutically active proteins are pasteurized without substantial loss of therapeutic activity by mixing the protein composition with a pasteurization-stabilizing amount of a sugar or reduced sugar and of an amino acid prior to pasteurization. Pasteurized compositions containing therapeutically active proteins, which have heretofore been unattainable, can be prepared by the method of the invention.

Pasteurized therapeutically active protein compositions

Methods for producing substantially pure pyranosone from pyranose, especially glucosone from glucose. A pyranose-2-oxidase enzyme which is free of substantially all glucosone-utilizing enzyme contaminants which are measurably active at a selected pH between about 4.4 and 7.0 is reacted in solution with a pyranose and oxygen to produce the corresponding pyranosone. Hydrogen peroxide co-produced in the reaction is maintained at a concentration below about 10.sup.-3 M, by substantially pure catalase. The reaction is carried out at the selected pH. The methods and reagents are also applicable to producing xylosone from xylose, 5-ketofructose from sorbose, and mixtures of 2-ketogluconic and isoascorbic acid from delta-gluconolactone.

Methods and reagents for pyranosone production

An improved process for recovering and purifying .beta.-HIFN from transformed bacterial comprising concentrating the bacteria; disrupting the cell wall and solubilizing the .beta.-HIFN into an aqueous medium with an appropriate solubilizing agent; extracting the .beta.-HIFN from the aqueous medium with 2-butanol, 2-methyl-2-butanol or mixtures thereof; precipitating and isolating the .beta.-HIFN from the alcohol phase; purifying the .beta.-HIFN by chromatography and diafiltering the .beta.-HIFN against distilled water or aqueous solutions of ethanol or glycerol at a pH of about 12; and therapeutic formulations and compositions of .beta.-HIFN within SDS levels therein reduced to less than 10 p.p.m.

Process for the recovery of human .beta.-interferon-like polypeptides

Compositions containing thermally sensitive, therapeutically active proteins are pasteurized without substantial loss of therapeutic activity by mixing the protein composition with a pasteurization-stabilizing amount of a polyol prior to pasteurization. Pasteurized compositions containing therapeutically active proteins, which have heretofore been unattainable, can be prepared by the method of the invention.

Composition comprising an aqueous solution of immune serum globulin and maltose, the amount of maltose being sufficient to inhibit 'shedding' of the globulin with time.

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Concord, CA, United States of America

Peter M Fernandes