Patent US4105029A successfully refreshed from Google Patents.
US4534972A
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Protein compositions substantially free from infectious agents
Assignee: Bayer Corp
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Filing: 1983-03-29
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Granted: 1985-08-13
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Expires: 2003-03-29
Abstract
Abstract Compositions containing therapeutically or immunologically active proteins are rendered substantially free from infectious agents such as viable viruses and bacteria without substantial loss of therapeutic or immunologic activity by mixing the protein composition with a complex formed from source of transition metal ions, such as copper ions, and an angularly-fused, polynuclear heterocyclic arene having two nitrogen atoms in a "cis-ortho" relationship, such as phenanthroline, and a reducing agent such as a thiol in amounts and at a temperature and for a time sufficient to inactivate substantially all of the viruses and bacteria contained therein. Compositions containing therapeutically active proteins substantially free from viral and bacterial infectivity, which have heretofore been unattainable, can be prepared by the method of the invention.
Inventors
- 👤 Kenneth J. Lembach
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:53
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/13; A61K31/14; A61K35/00; A61K35/12; A61K35/14; A61K35/16; A61K38/00; A61K39/00; A61L; A61L2/00; A61L2/02; A61L2/04; A61L2/16; A61L2/18; A61L2103/00; A61L2103/05; Y; Y10; Y10S; Y10S530/00; Y10S530/806; Y10S530/82; Y10S530/825; Y10S530/826
Claims Analysis
Total Claims: 19
Claim 1
Independent Claim
165 words
A method for rending a composition, which contains a therapeutically or immunologically active protein, selected from the group consisting of blood plasma proteins, virus vaccines, bacterial vaccines, and non-infectious antigens dissolved in an aqueous medium, substantially free from infectious agents selected from viable viruses and bacteria without substantial loss of therapeutic or immunologic activity, which comprises (a) mixing an aqueous solution of the protein composition with an effective amount of a complex formed from mixing an angularly-fused, polynuclear heterocyclic arene have two nitrogen atoms in a "cis-ortho" relationship and a source of transition metal ions capable of complexing with said arene and a thiol in effective amounts to inactivate substantially all of the infectious agents contained in said composition and which does not result in substantial loss of therapeutic or immunological activity and (b) holding the mixture for a time and at a temperature sufficient to render said infectious agents substantially non-infective in the protein composition without substantial loss of therapeutic or immunologic activity therein.
Claim 2
Independent Claim
165 words
A method for rending a composition, which contains a therapeutically or immunologically active protein, selected from the group consisting of blood plasma proteins, virus vaccines, bacterial vaccines, and non-infectious antigens dissolved in an aqueous medium, substantially free from infectious agents selected from viable viruses and bacteria without substantial loss of therapeutic or immunologic activity, which comprises (a) mixing an aqueous solution of the protein composition with an effective amount of a complex formed from mixing an angularly-fused, polynuclear heterocyclic arene have two nitrogen atoms in a "cis-ortho" relationship and a source of transition metal ions capable of complexing with said arene and a thiol in effective amounts to inactivate substantially all of the infectious agents contained in said composition and which does not result in substantial loss of therapeutic or immunological activity and (b) holding the mixture for a time and at a temperature sufficient to render said infectious agents substantially non-infective in the protein composition without substantial loss of therapeutic or immunologic activity therein.
Claim 3
Dependent Claim
29 words
The method of claim 1 wherein the mixture is held in step (b) at a temperature of about 2°-60° C. for a period of at least about 0.25 hours.
Claim 4
Dependent Claim
27 words
The method of claim 1 wherein the mixture is held in step (b) at a temperature of about 20°-37° C. for a period of about 0.5-3 hours.
Claim 5
Dependent Claim
32 words
The method of claim 1 wherein the mixture is held for a time and at a temperature to inactivate at least about 99% of the viruses and bacteria in the protein composition.
Claim 6
Dependent Claim
14 words
The method of claim 1 wherein the pH in step (b) is physiologically compatible.
Claim 7
Dependent Claim
11 words
The method of claim 1 wherein the pH is about 4-10.
Claim 8
Dependent Claim
28 words
The method of claim 1 wherein the amount of complex in step (a) is about 0.001-0.1 mM in an about 0.5-2% (weight/volume) aqueous solution of the protein composition.
Claim 9
Dependent Claim
26 words
The method of claim 1 wherein the amount of reducing agent is about 0.1-5 mM in an about 0.5-2% (weight/volume) aqueous solution of the protein composition.
Claim 10
Dependent Claim
12 words
The method of claim 1 wherein the complex is a copper/1,10-phenanthroline complex.
Claim 11
Dependent Claim
12 words
The method of claim 1 wherein the reducing agent is 3-mercaptopropionic acid.
Claim 12
Dependent Claim
16 words
The method of claim 1 wherein the protein composition comprises an component derived from blood plasma.
Claim 13
Dependent Claim
13 words
The method of claim 1 wherein the protein composition comprises a viral vaccine.
Claim 14
Dependent Claim
12 words
The method of claim 1 wherein the protein composition comprises non-infectious antigen.
Claim 15
Dependent Claim
102 words
The method of claim 1 wherein the protein composition comprises a protein selected from the group consisting of blood plasma, partially fractionated blood plasma, plasminogen, albumin, antihemophilic factor (Factor VIII), Factor IX concentrate containing Factors II, VII, IX and X, and the individual factors, Plasma Protein Fraction (human), fibronectin (cold insoluble globulin), Factor XIII, IgG, IgA, IgD, IgE, IgM, high molecular weight kininogen (90,000-106,000), an immune globulin, intravenous (modified, either chemically or enzymatically or by fractional separation, immune serum globulin, anti-inhibitor coagulant complex, antithrombin III, alpha-1-proteinase inhibitor, plasma growth hormone, somatomedin, prealbumin, plasminogen-streptokinase complex, ceruloplasmin, transferrin, haptoglobin, and prekallikrein and mixtures thereof.
Claim 16
Dependent Claim
12 words
The substantially non-infective protein composition produced by the method of claim 12.
Claim 17
Dependent Claim
12 words
The substantially non-infective protein composition produced by the method of claim 13.
Claim 18
Dependent Claim
12 words
The substantially non-infective protein composition produced by the method of claim 14.
Claim 19
Dependent Claim
12 words
The substantially non-infective protein composition produced by the method of claim 15.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-08-12 | 1989-02-11 | 1989-08-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-08-12 | 1993-02-11 | 1993-08-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-08-12 | 1997-02-11 | 1997-08-13 | $7700.00 | Window Closed / Lapsed |