US4440679A
Expired / Lapsed
US
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Pasteurized therapeutically active protein compositions
Assignee: Bayer Corp
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Filing: 1982-12-20
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Granted: 1984-04-03
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Expires: 2002-12-20
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
US
Data Source
google_patents
Last Synchronized
2026-10-23 19:33
CPC Classifications
C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/6445; A; A61; A61K; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61K38/00; A61K38/16; A61K38/17; A61K38/36; A61K38/363; A61K38/37; A61K38/38; 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; C12N9/96; A61L2103/00; A61L2103/05; A61L2103/09
Claims Analysis
Total Claims: 28
Claim 1
Independent Claim
111 words
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°-75° 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.
Claim 2
Independent Claim
111 words
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°-75° 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.
Claim 3
Dependent Claim
17 words
The method of claim 1 wherein the molecular weight of the compound is about 5000 or less.
Claim 4
Dependent Claim
20 words
The method of claim 1 wherein the mixture is heated in Step b at a temperature of about 62°-65° C.
Claim 5
Dependent Claim
17 words
The method of claim 1 wherein the mixture is heated for a period of about 10 hours.
Claim 6
Dependent Claim
20 words
The method of claim 1 which further includes the step of removing the compound from the mixture of Step b.
Claim 7
Dependent Claim
24 words
The method of claim 5 wherein the compound is removed from the mixture of Step b by subjecting the mixture to diafiltration or dialysis.
Claim 8
Dependent Claim
19 words
The method of claim 5 which further includes the step of removing water from the mixture of Step b.
Claim 9
Dependent Claim
23 words
The method of claim 7 wherein water is removed from the mixture of Step b by subjecting the mixture to ultrafiltration or freeze-drying.
Claim 10
Dependent Claim
19 words
The method of claim 1 wherein about 1-1000 parts of compound are mixed with 1 part of total protein.
Claim 11
Dependent Claim
27 words
A composition comprising a protein selected from the group consisting of antihemophilic factor (Factor VIII), fibronectin, fibrinogen, alpha-1-antitrypsin and prekallikrein produced by the method of claim 1.
Claim 12
Dependent Claim
9 words
A pharmaceutical preparation comprising a composition of claim 10.
Claim 13
Independent Claim
88 words
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°-75° 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.
Claim 14
Independent Claim
88 words
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°-75° 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.
Claim 15
Dependent Claim
19 words
The method of claim 12 wherein about 1-1000 parts of compound are mixed with 1 part of total protein.
Claim 16
Dependent Claim
20 words
The method of claim 12 wherein about 1-500 parts of the aqueous solution are mixed with one part of concentrate.
Claim 17
Dependent Claim
20 words
The method of claim 12 wherein the mixture is heated in Step b at a temperature of about 62°-65° C.
Claim 18
Dependent Claim
17 words
The method of claim 12 wherein the mixture is heated for a period of about 10 hours.
Claim 19
Dependent Claim
20 words
The method of claim 12 which further includes the step of removing the compound from the mixture of Step b.
Claim 20
Dependent Claim
24 words
The method of claim 17 wherein the compound is removed from the mixture of Step b by subjecting the mixture to diafiltration or dialysis.
Claim 21
Dependent Claim
19 words
The method of claim 16 which further includes the step of removing water from the mixture of Step b.
Claim 22
Dependent Claim
23 words
The method of claim 19 wherein water is removed from the mixture of Step b by subjecting the mixture to ultrafiltration or freeze-drying.
Claim 23
Dependent Claim
12 words
A pasteurized antihemophilic factor concentrate produced by the method of claim 12.
Claim 24
Dependent Claim
12 words
A pharmaceutical preparation comprising the pasteurized antihemophilic factor concentrate of claim 21.
Claim 25
Independent Claim
134 words
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°-75° 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.
Claim 26
Independent Claim
134 words
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°-75° 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.
Claim 27
Dependent Claim
21 words
The method of claim 23 wherein about 1-500 parts of the aqueous medium are mixed with one part of protein composition.
Claim 28
Dependent Claim
27 words
The method of claim 23 wherein the mixture is heated in Step b at a temperature of about 62°-65° C. for a period of about 10 hours.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-04-03 | 1987-10-03 | 1988-04-03 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-04-03 | 1991-10-03 | 1992-04-03 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-04-03 | 1995-10-03 | 1996-04-03 | $7700.00 | Window Closed / Lapsed |