US4379087A
Expired / Lapsed
US
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Method of preparing alpha-1-proteinase inhibitor
Assignee: Bayer Corp
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Filing: 1982-06-17
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Granted: 1983-04-05
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Expires: 2002-06-17
Abstract
Abstract A method is disclosed for separating alpha-1-proteinase inhibitor from a blood plasma fraction particularly from the Cohn fractionation scheme. An aqueous solution of the blood plasma fraction is held at a pH of about 6.5-8.5, and a temperature of about 2 DEG -50 DEG C. for a period of about 0.2-24 hours and then mixed with a poly-condensed polyglycol in a proportion of about 10-15 parts of polymer per 100 ml of aqueous solution containing the blood plasma fraction. The mixture may be held at a temperature of about 2 DEG -10 DEG C. for a period of about 1-24 hours. Next, the pH of the mixture is adjusted to about 4.6-5.7, to selectively precipitate unwanted proteins from the solution of alpha-1-proteinase inhibitor which is separated from the solution and purified further.
Inventors
- 👤 Michael H. Coan
- 👤 William J. Brockway
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 03:54
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/81; C07K14/8107; C07K14/811; C07K14/8121; C07K14/8125; A; A61; A61K; A61K38/00; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83; Y10S530/831
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
108 words
A method for separating alpha-1-proteinase inhibitor from a blood plasma fraction containing the same, which comprises the steps of (a) holding an aqueous solution of the blood plasma fraction at a pH of about 6.5-8.5, and a temperature of about 2°-50° C. for a period of about 0.2-24 hours, (b) mixing the solution with a polycondensed polyglycol in the proportion of about 10-15 grams of polyglycol per 100 ml of aqueous solution containing the blood plasma fraction and adjusting the pH of the mixture to about 4.6-5.7 to selectively precipitate unwanted proteins from the solution without precipitation of alpha-1-proteinase inhibitor, and (c) separating alpha-1-proteinase inhibitor from the solution.
Claim 2
Independent Claim
108 words
A method for separating alpha-1-proteinase inhibitor from a blood plasma fraction containing the same, which comprises the steps of (a) holding an aqueous solution of the blood plasma fraction at a pH of about 6.5-8.5, and a temperature of about 2°-50° C. for a period of about 0.2-24 hours, (b) mixing the solution with a polycondensed polyglycol in the proportion of about 10-15 grams of polyglycol per 100 ml of aqueous solution containing the blood plasma fraction and adjusting the pH of the mixture to about 4.6-5.7 to selectively precipitate unwanted proteins from the solution without precipitation of alpha-1-proteinase inhibitor, and (c) separating alpha-1-proteinase inhibitor from the solution.
Claim 3
Dependent Claim
19 words
The method of claim 1 wherein 1 part of polyglycol is used per 0.5-0.8 parts of blood plasma fraction.
Claim 4
Dependent Claim
40 words
The method of claim 1 wherein the mixture of the solution with the polyglycol is held at a temperature of about 2°-10° C. for a period of about 1-24 hours prior to the adjustment of the pH of the mixture.
Claim 5
Dependent Claim
20 words
The method of claim 1 which further includes the step of treating the alpha-1-proteinase inhibitor to render it hepatitis non-infective.
Claim 6
Dependent Claim
47 words
The method of claim 4 wherein the alpha-1-proteinase inhibitor is rendered hepatitis non-infective by heating an aqueous solution of the alpha-1-proteinase inhibitor in the presence of a heat stabilizing agent for a time and at a temperature and pH sufficient to render the alpha-1-proteinase inhibitor hepatitis non-infective.
Claim 7
Dependent Claim
16 words
The method of claim 5 wherein the heat stabilizing agent is a source of citrate ions.
Claim 8
Dependent Claim
13 words
The method of claim 5 wherein the heat stabilizing agent is a carbohydrate.
Claim 9
Dependent Claim
22 words
The method of claim 5 wherein the heat stabilizing agent is a mixture of a carbohydrate and a source of citrate ions.
Claim 10
Dependent Claim
31 words
The method of claim 5 wherein the alpha-1-proteinase inhibitor is heated for about 60° C. or more for a period up to about 10 hours at a pH of about 6.0-7.0.
Claim 11
Dependent Claim
25 words
The method of claim 1 wherein an effluent solution is separated from a precipitate in Step b prior to adjusting the pH of the mixture.
Claim 12
Dependent Claim
58 words
The method of claim 1 wherein the alpha-1-proteinase inhibitor is separated from the solution in Step c by (d) separating a supernatant solution containing alpha-1-proteinase inhibitor from a precipitate, (e) contacting the solution with an anion exchange medium at a pH of about 5.5-8.6, and (f) selectively separating an effluent containing alpha-1-proteinase inhibitor from the anion exchange medium.
Claim 13
Dependent Claim
18 words
The method of claim 11 wherein the effluent of Step f is treated to reduce its water content.
Claim 14
Dependent Claim
29 words
The method of claim 1 wherein the blood plasma fraction containing alpha-1-proteinase inhibitor is selected from the group consisting of Cohn Fraction IV-1, Cohn Fraction IV, and their reworks.
Claim 15
Dependent Claim
33 words
The method of claim 1 wherein the alpha-1-proteinase inhibitor is separated from the mixture in Step e by contacting the mixture with a polycondensed polyglycol and separating an effluent therefrom containing alpha-1-proteinase inhibitor.
Claim 16
Dependent Claim
12 words
The method of claim 1 wherein the polycondensed polyglycol is polyethylene glycol.
Claim 17
Dependent Claim
16 words
The method of claim 15 wherein the molecular weight of the polyethylene glycol is about 3000-4000.
References Cited (Backward Citations)
US3415804A
Cited
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1986-04-04 | 1986-10-04 | 1987-04-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1990-04-04 | 1990-10-04 | 1991-04-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1994-04-04 | 1994-10-04 | 1995-04-05 | $7700.00 | Window Closed / Lapsed |