Pasteurized therapeutically active protein compositions
AssigneeMiles Laboratories, Inc.
InventorsPeter M. Fernandes, John L. Lundblad
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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 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.
Claims19
A method of pasteurizing a composition comprising a thermally sensitive, therapeutically active protein selected from the group consisiting of antihemophilic factor (Factor VIII), fibronectin, antithrombin III, alpha-1-antitrypsin, and prekallikrein, which comprises
- (a) mixing the protein composition with from 0.1 to 0.5 M of at least one amino acid and 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 54% 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 at least about 10 hours to pasteurize the protein composition and render it substantially free of infective hepatitis.
Dependencies are inferred from the claim text.