US4721777A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process for the virus-inactivation of immunoglobulin
Assignee: Tanabe Pharma Corp
•
Filing: 1985-09-23
•
Granted: 1988-01-26
•
Expires: 2005-09-23
Abstract
Abstract Virus-contaminated immunoglobulin can be virus-inactivated by heating it in a substantially dry state at a temperature of 30° to 100° C. for a period of time sufficient for inactivating virus with maintaining original activity of the immunoglobulin. The addition of glycine, sodium chloride, sodium acetate, polyethylene glycol, albumin or mannitol enhances the effect and gives good solubility and good state to the solution of the virus-inactivated immunoglobulin.
Inventors
- 👤 Yahiro Uemura
- 👤 Katuhiro Uriyu
- 👤 Tsuyoshi Takahashi
- 👤 Takashi Goto
- 👤 Masahiro Funayama
- 👤 Masayuki Nishida
- 👤 Tadakazu Suyama
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 04:56
CPC Classifications
A; A61; A61K; A61K39/00; A61K39/395; A61K39/39591; A61L; A61L2/00; A61L2/02; A61L2/04; A61L2103/00; A61L2103/05; Y; Y10; Y10S; Y10S530/00; Y10S530/861; Y10S530/863
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
46 words
A process for virus-inactivating immunoglobulin comprising heating a composition containing the immunoglobulin in a substantially dry state at a temperature of 30° to 100° C. for a period of time sufficient to inactivate virus contained in the composition without destroying the activity of the immunoglobulin itself.
Claim 2
Dependent Claim
46 words
A process for virus-inactivating immunoglobulin comprising heating a composition containing the immunoglobulin in a substantially dry state at a temperature of 30° to 100° C. for a period of time sufficient to inactivate virus contained in the composition without destroying the activity of the immunoglobulin itself.
Claim 3
Dependent Claim
36 words
A process according to claim 1, wherein the composition contains a stabilizer selected from the group consisting of glycine, alkalimetal chloride, alkalimetal acetate, polyethylene glycol, albumin and mannitol in an amount sufficient to stabilize the immunoglobulin.
Claim 4
Dependent Claim
22 words
A process according to claim 1, wherein the composition subjected to said heating comprises purified immunoglobulin suitable for administration to a patient.
Claim 5
Dependent Claim
19 words
A process according to claim 1, wherein the composition is lyophilized to the substantially dry state before said heating.
Claim 6
Dependent Claim
19 words
A process according to claim 1, wherein the composition as heated has a moisture content of 3% or less.
Claim 7
Dependent Claim
16 words
A process according to claim 1, wherein the immunoglobulin is of human, horse or mouse origin.
Claim 8
Dependent Claim
20 words
A process according to claim 6, wherein the immunoglobulin of human or mouse is a polyclonal or a monoclonal antibody.
Claim 9
Dependent Claim
14 words
A process according to claim 1, wherein the immunoglobulin is IgG, IgA or IgM.
Claim 10
Dependent Claim
21 words
A process according to claim 2, wherein the stabilizer is selected from the group consisting of alkalimetal chloride and alkalimetal acetate.
Claim 11
Dependent Claim
11 words
A process according to claim 9, wherein the alkalimetal is sodium.
Claim 12
Dependent Claim
45 words
A process according to claim 2, wherein the amount sufficient for stabilizing immunoglobulin corresponds to a concentration of the stabilizer of 0.01 to 4% (w/v) relative to 0.01 to 2% (w/v) solution of monoclonal immunoglobulin or 2 to 8% (w/v) solution of a polyclonal immunoglobulin.
Claim 13
Dependent Claim
35 words
A process according to claim 2, wherien the stabilizer is added to a solution of the composition after which the composition is lyophilized to the substantially dry state before it is heated to inactivate virus.
Claim 14
Dependent Claim
11 words
A virus-inactivated immunoglobulin prepared according to the process of claim 2.
Claim 15
Dependent Claim
70 words
A process according to claim 1 for inactivating any virus present in immunoglobulin which comprises adding a stabilizing amount of glycine to a solution of the immunoglobulin; lyopilizing said solution to a moisture content of 0.05 to 3%; and then heating the lyophilized composition for a period of 10-100 hours at about 60° C. to inactivate any virus without inactivating the immunoglobulin, the thus-treated immunoglobulin demonstrating improved stability and water-solubility.
References Cited (Backward Citations)
EP0035204A2
Cited
US4440679A
Cited
US4327086A
Cited
JPS58500548A
Cited
US4446134A
Cited
EP0094611A2
Cited
JPS58213721A
Cited
EP0124506A2
Cited
EP0159311B1
Cited
US4590002A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1991-01-25 | 1991-07-27 | 1992-01-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-01-25 | 1995-07-27 | 1996-01-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-01-25 | 1999-07-27 | 2000-01-26 | $7700.00 | Window Closed / Lapsed |