EP0035204A2
Expired / Lapsed
EP
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Pasteurized therapeutically active protein compositions
Assignee: Bayer Corp
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Filing: 1981-02-23
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Granted: —
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Expires: 2001-02-23
Abstract
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.
Inventors
- 👤 Peter M. Fernandes
- 👤 John L. Lundblad
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-04 05:20
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K38/17; A61K38/36; A61K38/37; A61K31/00; A61K31/13; A61K31/14; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61K38/363; A61K38/38; A61K38/39; A61K38/43; A61K38/46; A61K38/48; A61K38/482; A61K38/484; A61K38/4853; A61K39/00; A61K39/395; A61K39/39591; A61L; A61L2/00; A61L2/02; A61L2/04; C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/6445; C12N9/96; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
60 words
A protein composition substantially free of infective hepatitis comprising a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin, Factor VIII inhibiting bypass activity substance, a modified immune serum globulin, fibrinogen, α-1-antitrypsin, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, transferrin, haptoglobin, defatted albumin, defatted Plasma Protein Fraction (human), kininogen, hemoglobin and prekallikrein.
Claim 2
Dependent Claim
60 words
A protein composition substantially free of infective hepatitis comprising a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin, Factor VIII inhibiting bypass activity substance, a modified immune serum globulin, fibrinogen, α-1-antitrypsin, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, transferrin, haptoglobin, defatted albumin, defatted Plasma Protein Fraction (human), kininogen, hemoglobin and prekallikrein.
Claim 3
Dependent Claim
60 words
A pasteurized composition comprising a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin plasma, an immune serum globulin, Factor VIII inhibiting bypass activity substance, a modified immune serum globulin, fibrinogen, a-1-antitrypsin, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, transferin, haptoglogin, defatted albumin, defatted Plasma Protein Fraction (human) kininogen, hemoglobin and prekallikrein.
Claim 4
Dependent Claim
60 words
A pasteurized composition comprising a thermally sensitive, therapeutically active protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin plasma, an immune serum globulin, Factor VIII inhibiting bypass activity substance, a modified immune serum globulin, fibrinogen, a-1-antitrypsin, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, transferin, haptoglogin, defatted albumin, defatted Plasma Protein Fraction (human) kininogen, hemoglobin and prekallikrein.
Claim 5
Dependent Claim
8 words
The freeze-dried composition of claim 1 or 2.
Claim 6
Independent Claim
67 words
A method for pasteurizing a composition containing a thermally sensitive, therapeutically active protein capable of being stabilized during pasteurization in the presence of a polyol, which comprises -- (a) mixing the composition with a polyol, said polyol being present in an amount sufficient to stabilize the protein during pasteurization and (b) heating the mixture at a temperature and for a time sufficient to pasteurize the protein composition.
Claim 7
Independent Claim
67 words
A method for pasteurizing a composition containing a thermally sensitive, therapeutically active protein capable of being stabilized during pasteurization in the presence of a polyol, which comprises -- (a) mixing the composition with a polyol, said polyol being present in an amount sufficient to stabilize the protein during pasteurization and (b) heating the mixture at a temperature and for a time sufficient to pasteurize the protein composition.
Claim 8
Dependent Claim
28 words
The method of claim 4 wherein the composition is mixed with an aqueous solution containing about 10% to saturation of a polyol, on a weight to volume basis.
Claim 9
Dependent Claim
30 words
The method of claim 4 or 5 wherein the composition in Step a is mixed further with an amino acid in an amount sufficient to stabilize the composition during pasteurization.
Claim 10
Independent Claim
21 words
The method of claims 4 to 6 wherein the pH of the mixture of Step a is about 5.5 - 8.0.
Claim 11
Independent Claim
46 words
A method for imparting thermal stability at a temperature of about 60-75 0 C. to a composition containing a thermally sensitive therapeutically active protein capable of being stabilized in the presence of a polyol which comprises incorporating into said composition a polyol in a thermal-stabilizing amount.
Claim 12
Independent Claim
46 words
A method for imparting thermal stability at a temperature of about 60-75 0 C. to a composition containing a thermally sensitive therapeutically active protein capable of being stabilized in the presence of a polyol which comprises incorporating into said composition a polyol in a thermal-stabilizing amount.
Claim 13
Independent Claim
65 words
The method of claims 4 to 8 wherein the thermally sensitive, therapeutically active protein is 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), Factor VIII inhibiting bypass activity substance, fibrinogen, a-l-antitrypson, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, hemoglobin, transferrin, haptoglobin, kininogen and prekallikrein.
Claim 14
Dependent Claim
44 words
1 0. The method of claims 4 to 9 wherein the protein composition in Step a is mixed further with an amino acid in an amount sufficient to stabilize the protein during pasteurization and the pH of the mixture is about 5.5 - 8.0.
References Cited (Backward Citations)
No citation records indexed.
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