US4645830A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Stable composition of interleukin-2 and albumin
Assignee: Takeda Pharmaceutical Co Ltd
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Filing: 1985-04-08
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Granted: 1987-02-24
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Expires: 2005-04-08
Abstract
Abstract The present invention provides an interleukin-2 composition which comprises human serum albumin, a reducing compound or a combination thereof and is adjusted as showing pH of 3 to 6 as a solution. The composition of the present invention is characterized in that interleukin-2 activity is minimized during storage and in the processes of freezing and lyophilization.
Inventors
- 👤 Mikura Yasushi
- 👤 Asada Kensuke
- 👤 Toguchi Hajime
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 13:13
CPC Classifications
A; A61; A61K; A61K38/00; A61K38/16; A61K47/00; A61K47/30; A61K47/42; A61K38/17; A61K38/19; A61K38/20; A61K38/2013; A61K47/06; A61K47/16; A61K47/18; A61K47/183; A61K9/00; A61K9/0012; A61K9/0019; A61K9/14; A61K9/19; Y; Y10; Y10S; Y10S435/00; Y10S435/8215; Y10S435/948; Y10S530/00; Y10S530/827; Y10S530/828; Y10S930/00; Y10S930/01; Y10S930/14; Y10S930/141
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
47 words
A human interleukin-2 composition in the form of a lyophilizate which comprises in addition to human interleukin-2, human serum albumin in a concentration of about 0.1 to 50 mg/ml as an aqueous solution, and, as a solution, is adjusted to have a pH between 3 to 6.
Claim 2
Dependent Claim
47 words
A human interleukin-2 composition in the form of a lyophilizate which comprises in addition to human interleukin-2, human serum albumin in a concentration of about 0.1 to 50 mg/ml as an aqueous solution, and, as a solution, is adjusted to have a pH between 3 to 6.
Claim 3
Dependent Claim
13 words
The composition according to claim 1, wherein the interleukin-2 is a recombinant interleukin-2.
Claim 4
Dependent Claim
15 words
The composition according to claim 1, wherein the human interleukin-2 is a non-glycosylated human interleukin-2.
Claim 5
Dependent Claim
18 words
The composition according to claim 1, wherein the interleukin-2 has a specific activity of 20,000 to 80,000 units/mg.
Claim 6
Dependent Claim
22 words
The composition according to claim 1, wherein the interleukin-2 is in a concentration of 1 to 80,000 units/ml as an aqueous solution.
Claim 7
Dependent Claim
12 words
The composition according to claim 1, which is free from a salt.
Claim 8
Dependent Claim
19 words
The composition according to claim 1, which comprises a combination of a human serum albumin and the reducing compound.
Claim 9
Dependent Claim
15 words
The composition according to claim 7, wherein the reducing compound is an acidic reducing compound.
Claim 10
Dependent Claim
27 words
The composition according to claim 8, wherein the acidic reducing compound is glutathione, thioctic acid, N-acetylcysteine, thioalkanoic acid of 1 to 7 carbon atoms or ascorbic acid.
Claim 11
Dependent Claim
21 words
The composition according to claim 7, wherein the reducing compound is in a concentration of 0.05-20 mg/ml as an aqueous solution.
Claim 12
Dependent Claim
27 words
The composition according to claim 1, which further comprises an monoamino aliphatic amino acid, a cyclic amino acid, a monosaccharide, a sugar alcohol or a combination thereof.
Claim 13
Dependent Claim
13 words
The composition according to claim 1, which further comprises monoamino aliphatic amino acid.
Claim 14
Dependent Claim
25 words
The composition according to claim 12, wherein the monoamino aliphatic amino acid is in a concentration of 5 to 50 mg/ml as an aqueous solution.
Claim 15
Dependent Claim
32 words
The composition according to claim 1, wherein the pH of the composition is adjusted by an acidic reducing compound, an acidic amino acid, a mineral acid or/and a buffer of organic acid.
Claim 16
Dependent Claim
13 words
The composition according to claim 1, wherein the pH is 3 to 5.5.
Claim 17
Dependent Claim
28 words
The composition according to claim 11, wherein the additional component is a monosaccharide, a sugar alcohol or a combination thereof in a concentration of 10 to 100 mg/ml.
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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) | 1990-02-23 | 1990-08-25 | 1991-02-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-02-23 | 1994-08-25 | 1995-02-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-02-23 | 1998-08-25 | 1999-02-24 | $7700.00 | Window Closed / Lapsed |