US3717708A
Expired / Lapsed
US
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Blood coagulation complex
Assignee: Bayer Corp
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Filing: 1968-10-24
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Granted: 1973-02-20
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Expires: 1988-10-24
Abstract
Abstract A lyophilized mixture of coagulation components of human origin useful in the treatment of patients, who bleed due to a congenital or acquired deficiency of one or more of the coagulation Factors II, VII, IX, X, prepared from human plasma collected in a citrate anticoagulant, free of heparin, free of thrombin, free of the activated form of Factor X, free of depressor activity, free of anti-complement activity, and comprising the coagulation components Factors II, VII, IX, X in essentially the same proportions as normal human plasma and of a potency equivalent to a specific activity of more than 0.5 clinical unit of each component per milligram of protein; and the process of preparing such product by selective adsorption and selective fractional elution.
Inventors
- 👤 S Wada
- 👤 M Mozen
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-25 05:05
CPC Classifications
C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/6429; C12Y; C12Y304/00; C12Y304/21; C12Y304/21005; A; A61; A61K; A61K38/00; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83; Y10S530/831
Claims Analysis
Total Claims: 8
Claim 1
Independent Claim
97 words
A sterile lyophilized storage stable intravenous injectable concentrate of citrated human plasma for controlling bleeding in hemophilia, free of heparin, thrombin, the activated form of Factor X, depressor activity and anticomplement activity, and containing the coagulation Factors II, VII, IX, X in non-activated form, in proportions substantially the same as in human plasma, and having a Factor IX reconstituted potency of at least about 2,000 percent that of normal plasma and a Factor IX specific activity of at least about 0.5 clinical unit per milligram protein and a Factor IX post-infusion biological half-life of about 20-50 hours.
Claim 2
Dependent Claim
97 words
A sterile lyophilized storage stable intravenous injectable concentrate of citrated human plasma for controlling bleeding in hemophilia, free of heparin, thrombin, the activated form of Factor X, depressor activity and anticomplement activity, and containing the coagulation Factors II, VII, IX, X in non-activated form, in proportions substantially the same as in human plasma, and having a Factor IX reconstituted potency of at least about 2,000 percent that of normal plasma and a Factor IX specific activity of at least about 0.5 clinical unit per milligram protein and a Factor IX post-infusion biological half-life of about 20-50 hours.
Claim 3
Dependent Claim
23 words
A plasma concentrate according to claim 1 having a Factor IX specific activity of at least about 0.9 clinical units per mg. protein.
Claim 4
Dependent Claim
15 words
A mixture of a plasma concentrate according to claim 1 and a NaCl-citrate electrolyte buffer.
Claim 5
Dependent Claim
140 words
A process for the production of a storage stable plasma concentrate of the mixture of the Factors II, VII, IX and X coagulation components of human plasma in non-activated form, free of heparin, thrombin, the activated form of Factor X, depressor activity and anticomplement activity, which comprises the steps of applying Cohn Supernatant I, Method 6 from unmodified citrated human plasma onto an ion exchange resin consisting essentially of cross-linked dextran chains with diethylaminoethyl groups attached by ether linkages to the glucose units of the polysaccharide chains, and adsorbing thereon said coagulation components of the plasma; selectively eluting the column with ammonium bicarbonate solution of a pH of from about 7.3 to about 8.2 and increasing molarity; separating the eluate fraction containing coagulation components; freezing the separated eluate fraction and removing the ammonium bicarbonate therefrom by lyophilizing the frozen fraction.
Claim 6
Dependent Claim
140 words
A process for the production of a storage stable plasma concentrate of the mixture of the Factors II, VII, IX and X coagulation components of human plasma in non-activated form, free of heparin, thrombin, the activated form of Factor X, depressor activity and anticomplement activity, which comprises the steps of applying Cohn Supernatant I, Method 6 from unmodified citrated human plasma onto an ion exchange resin consisting essentially of cross-linked dextran chains with diethylaminoethyl groups attached by ether linkages to the glucose units of the polysaccharide chains, and adsorbing thereon said coagulation components of the plasma; selectively eluting the column with ammonium bicarbonate solution of a pH of from about 7.3 to about 8.2 and increasing molarity; separating the eluate fraction containing coagulation components; freezing the separated eluate fraction and removing the ammonium bicarbonate therefrom by lyophilizing the frozen fraction.
Claim 7
Dependent Claim
21 words
The process of claim 4 wherein the ammonium bicarbonate solution eluting the fraction containing the coagulation activity is about 0.75 M.
Claim 8
Dependent Claim
47 words
The process of claim 4 wherein the resin containing the adsorbed coagulation components is washed free of ceruloplasmin with ammonium bicarbonate solution of up to 0.3 molarity and the coagulation components are eluted with ammonium bicarbonate solution of about 0.75 M until thE Factor IX is eluted.
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) | 1976-02-20 | 1976-08-21 | 1977-02-20 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1980-02-20 | 1980-08-21 | 1981-02-20 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1984-02-20 | 1984-08-21 | 1985-02-20 | $7700.00 | Window Closed / Lapsed |