Pasteurized therapeutically active protein compositions
AssigneeCutter Laboratories, Inc.
InventorsPeter M. Fernandes, John L. Lundblad
Life of this patent
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Abstract
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.
Claims25
A method of pasteurizing a composition comprising a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin, plasminogen, antithrombin III, fibrinogen, alpha-1-antitrypsin, and prekallikrein, which comprises:
- (a) mixing the protein composition with a compound selected from the group consisting of sugars and reduced sugars in an aqueous medium said compound being present in the mixture in an amount of about 30% to saturation, on a weight to volume basis, and
- (b) heating the mixture at a temperature of about 60.degree.-75.degree. C. and a pH of about 5.5-8.0 for a time sufficient to pasteurize the protein composition and render it substantially free of infective hepatitis.
A method of pasteurizing an antihemophilic factor concentrate, which comprises:
- (a) mixing the concentrate with a compound selected from the group consisting of sugars and reduced sugars in an aqueous medium, said compound being present in the mixture in an amount of about 30% to saturation, on a weight to volume basis and
- (b) heating the mixture at a temperature of about 60.degree.-75.degree. C. and a pH of about 5.5-8.0 for a time sufficient to pasteurize the antihemophilic factor concentrate and render it substantially free of infective hepatitis.
A method for pasteurizing a composition containing a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin, plasminogen, albumin, an immune serum globulin, a modified immune serum globulin, antithrombin III, Plasma Protein Fraction (human), fibrinogen, alpha-1-antitrypsin, human blood plasma, partially fractionated human blood plasma and prekallikrein, which comprises:
- (a) mixing the protein composition with an aqueous medium containing a heat stabilizing compound consisting essentially of non-heat treated sugars and reduced sugars, said compound being present in the mixture in an amount of about 30% to saturation, on a weight to volume basis and
- (b) heating the mixture at a temperature of about 60.degree.-75.degree. C. and a pH of about 5.5-8.0 for a time sufficient to pasteurize the protein composition and render it substantially free of infective hepatitis.
Dependencies are inferred from the claim text.