US4522751A
Expired / Lapsed
US
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Method for producing a preparation containing factor VIII (AHF)
Assignee: Oesterreichisches Institut fuer Haemoderivate
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Filing: 1984-05-18
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Granted: 1985-06-11
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Expires: 2004-05-18
Abstract
Abstract There is described a method for producing a preparation having a high content of Factor VIII (AHF), i.e. with a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII. The method consists in that a Factor VIII containing plasma fraction is dissolved in a buffer, the solution is purified from undesired proteins by precipitation and is concentrated, the precipitation of undesired proteins being carried out in the presence of sulfated polysaccharide at a pH of from 6 to 7. After separation of the undesired proteins, a Factor VIII concentrate is precipitated, dissolved and processed into stable form. If desired, an antithrombin III-heparin complex or an antithrombin III-heparinoid complex is added to the solution.
Inventors
- 👤 Yendra Linnau
- 👤 Otto Schwarz
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 01:22
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/435; C07K14/745; C07K14/755; A; A61; A61P; A61P7/00; A61P7/04; A61K; A61K38/00; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
182 words
A method of producing a preparation containing Factor VIII (AHF) from a Factor-VIII-containing plasma fraction, said preparation containing Factor VIII (AHF) having a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII, said method comprising the steps of: (a) dissolving said Factor-VIII-containing plasma fraction in a buffer solution containing a sulfated polysaccharide at a pH value approximately in the neutral range; (b) lowering the pH to a value ranging from 6.0 to 6.4 and adjusting the temperature to between about 0° C. to about 25° C. to precipitate undesired proteins and obtain a Factor-VIII-containing supernatant; (c) adding at least one member of the group consisting of glycine, sodium chloride and sodium citrate, to said Factor-VIII-containing supernatant to maintain the major part of the immunoglobulins contained in said supernatant in solution; (d) adding a protein precipitating agent to obtain a Factor-VIII-containing precipitate; and (e) dissolving said Factor-VIII-containing precipatate in a solvent to obtain the final product.
Claim 2
Independent Claim
182 words
A method of producing a preparation containing Factor VIII (AHF) from a Factor-VIII-containing plasma fraction, said preparation containing Factor VIII (AHF) having a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII, said method comprising the steps of: (a) dissolving said Factor-VIII-containing plasma fraction in a buffer solution containing a sulfated polysaccharide at a pH value approximately in the neutral range; (b) lowering the pH to a value ranging from 6.0 to 6.4 and adjusting the temperature to between about 0° C. to about 25° C. to precipitate undesired proteins and obtain a Factor-VIII-containing supernatant; (c) adding at least one member of the group consisting of glycine, sodium chloride and sodium citrate, to said Factor-VIII-containing supernatant to maintain the major part of the immunoglobulins contained in said supernatant in solution; (d) adding a protein precipitating agent to obtain a Factor-VIII-containing precipitate; and (e) dissolving said Factor-VIII-containing precipatate in a solvent to obtain the final product.
Claim 3
Dependent Claim
16 words
A method as set forth in claim 1, wherein said Factor-VIII-containing plasma fraction is a cryoprecipitate.
Claim 4
Dependent Claim
28 words
A method as set forth in claim 1, wherein said sulfated polysaccharide is selected from the group consisting of mucopolysaccharide polysulfuric acid ester, pentosan polysulfate and dextran sulfate.
Claim 5
Dependent Claim
24 words
A method as set forth in claim 1, wherein the temperature in step (b) is adjusted to about 4° C. to about 8° C.
Claim 6
Dependent Claim
15 words
A method as set forth in claim 1, wherein said protein precipitating agent is ethanol.
Claim 7
Dependent Claim
37 words
A method as set forth in claim 1, wherein said Factor-VIII-containing precipitate is dissolved in a glycine-citrate-NaCl buffer solution in the presence of an antithrombin III-heparinoid complex or an antithrombin III-heparin complex, and processed into stable form.
Claim 8
Dependent Claim
77 words
A method as set forth in claim 1, wherein, upon adding said protein precipitating agent in step (d), a suspension is obtained, which is frozen and re-thawed at a temperature of from about 0° C. to about 4° C., to obtain a supernatant, which is discarded, and a Factor-VIII-containing precipitate, said Factor VIII-containing precipitate is dissolved in a glycine-citrate-NaCl buffer solution in the presence of antithrombin III-heparinoid complex or antitnrombin III-heparin complex, and processed into stable form.
Claim 9
Dependent Claim
19 words
A method as set forth in claim 1, wherein albumin is added to the final product for stabilizing purposes.
Claim 10
Dependent Claim
49 words
A preparation containing Factor VIII (AHF), having a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII produced according to claim 1.
Claim 11
Dependent Claim
49 words
A preparation containing Factor VIII (AHF), having a specific activity of at least 1.5 units of Factor VIII/mg protein, immunoglobulin G (IgG) of from 15 to 30 mg/1000 units of Factor VIII and fibrinogen of from 20 to 40 mg/100 units of Factor VIII produced according to claim 8.
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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) | 1988-06-10 | 1988-12-10 | 1989-06-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-06-10 | 1992-12-10 | 1993-06-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-06-10 | 1996-12-10 | 1997-06-11 | $7700.00 | Window Closed / Lapsed |