US4318902A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Concentrated immunoglobulin solution suited for intravenous administration
Assignee: Biotest AG
•
Filing: 1980-01-07
•
Granted: 1982-03-09
•
Expires: 2000-01-07
Abstract
Abstract A process for the preparation of an immunoglobulin solution containing IgM in concentrated form and suited for intravenous administration, comprising treating an IgM-containing protein fraction obtained by conventional fractionation from blood plasma or serum with β-propiolactone in an amount such that the ratio of β-propiolactone to a 5% solution of the IgM-containing proteins is from about 0.05 to 0.15 ml per 100 ml. Advantageously, prior to the treatment with β-propiolactone the IgM-containing protein fraction is freed of lipids by treatment with colloidal silica gel and with crosslinked dextrans or diethylaminoethyl cellulose. The starting material used is a Cohn fraction III of human blood plasma which has been dissolved in physiological saline solution to a concentration of about 5% protein, the treatment with β-propiolactone is carried out at about 20° to 37° C. for about 4 to 6 hours until a substantially constant pH of about 8 is obtained, and the solution is thereafter sterile filtered.
Inventors
- 👤 Wolfgang Stephan
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 11:13
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/395; A61K39/39591; Y; Y10; Y10S; Y10S424/00; Y10S424/806; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83; Y10S530/831; Y10S530/832; Y10S530/863
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
63 words
A process for the preparation of an immunoglobulin solution containing IgM in concentrated form and suited for intravenous administration, comprising treating an IgM-containing protein fraction obtained by conventional fractionation from blood plasma or serum with β-propiolactone in an amount such that the ratio of β-propiolactone to a 5% solution of the IgM-containing proteins is from about 0.05 to 0.15 ml per 100 ml.
Claim 2
Dependent Claim
63 words
A process for the preparation of an immunoglobulin solution containing IgM in concentrated form and suited for intravenous administration, comprising treating an IgM-containing protein fraction obtained by conventional fractionation from blood plasma or serum with β-propiolactone in an amount such that the ratio of β-propiolactone to a 5% solution of the IgM-containing proteins is from about 0.05 to 0.15 ml per 100 ml.
Claim 3
Dependent Claim
38 words
A process according to claim 1, wherein the treatment with β-propiolactone is carried out for about 2 to 10 hours at a temperature ranging from about 20° to 37° C. and a pH between about 7 and 8.5.
Claim 4
Dependent Claim
35 words
A process according to claim 1, wherein the starting material used is a Cohn fraction III of human blood plasma which has been dissolved in physiological saline solution to a concentration of about 5% protein.
Claim 5
Dependent Claim
34 words
A process according to claim 1, wherein prior to the treatment with β-propiolactone the IgM-containing protein fraction is freed of lipids by treatment with colloidal silica gel and with crosslinked dextrans or diethylaminoethyl cellulose.
Claim 6
Dependent Claim
30 words
A process according to claim 1, wherein the treatment with β-propiolactone is carried out until a substantially constant pH value is obtained and the solution obtained is thereafter sterile filtered.
Claim 7
Dependent Claim
71 words
A process according to claim 4, wherein the starting material used is a Cohn fraction III of human blood plasma which has been dissolved in physiological saline solution to a concentration of about 5% protein, the treatment with β-propiolactone is carried out at about 20° to 37° C. for about 4 to 6 hours until a substantially constant pH of about 8 is obtained, and the solution is thereafter sterile filtered.
Claim 8
Dependent Claim
63 words
An intravenously injectable IgM-containing solution produced by the process of claim 1, having a maximum complement consumption per ml at a 30-fold dilution of 0.3, exhibiting at least about 70% of the antibody activity of the initial protein fraction against E. coli, Klebsiella, Pyocyaneus, Streptococcus viridans, Streptococcus haemolyticus, Enterococci and Staphylococci and having an IgM content of about 10% based on total globulins.
Claim 9
Dependent Claim
63 words
An intravenously injectable IgM-containing solution produced by the process of claim 6, having a maximum complement consumption per ml at a 30-fold dilution of 0.3, exhibiting at least about 70% of the antibody activity of the initial protein fraction against E. coli, Klebsiella, Pyocyaneus, Streptococcus viridans, Streptococcus haemolyticus, Enterococci and Staphylococci and having an IgM content of about 10% based on total globulins.
Claim 10
Dependent Claim
18 words
In the intravenous administration of IgM, the improvement which comprises employing an IgM-containing solution according to claim 7.
Claim 11
Dependent Claim
18 words
In the intravenous administration of IgM, the improvement which comprises employing an IgM-containing solution according to claim 8.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1985-03-08 | 1985-09-07 | 1986-03-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1989-03-08 | 1989-09-07 | 1990-03-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1993-03-08 | 1993-09-07 | 1994-03-09 | $7700.00 | Window Closed / Lapsed |