EP0158487A2
Expired / Lapsed
EP
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Stable composition of interleukin-2
Assignee: Takeda Pharmaceutical Co Ltd
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Filing: 1985-03-28
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Granted: —
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Expires: 2005-03-28
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 characterised in that the interleukin-2 activity is lost little during storage and in the process of freezing and lyophilization
Inventors
- 👤 Yasushi Mikura
- 👤 Kensuke Asada
- 👤 Hajime Toguchi
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 04:38
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: 30
Claim 1
Independent Claim
28 words
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.
Claim 2
Dependent Claim
28 words
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.
Claim 3
Dependent Claim
12 words
The composition according to Claim 1, wherein the interleukin-2 is human interleukin-2.
Claim 4
Dependent Claim
15 words
The composition according to Claim 1 or 2, wherein the interleukin-2 is a recombinant interleukin-2.
Claim 5
Dependent Claim
17 words
The composition according to Claim 2, wherein the human interleu - kin-2 is a non-glycosylated human interleukin-2.
Claim 6
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 7
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 8
Dependent Claim
12 words
The composition according to Claim 1, which is free from a salt.
Claim 9
Dependent Claim
12 words
The composition according to Claim 1, which comprises the human serum albumin.
Claim 10
Dependent Claim
24 words
The composition according to Claim 8, wherein the human serum albumin is in a concentration of 0.1 to 50 mg/ml as an aqueous solution.
Claim 11
Dependent Claim
11 words
The composition according to Claim 1, which comprises the reducing compound.
Claim 12
Dependent Claim
15 words
The composition according to Claim 10, wherein the reducing compound is an acidic reducing compound.
Claim 13
Dependent Claim
27 words
The composition according to Claim 11, wherein the acidic reducing compound is glutathione, thioctic acid, N-acetylcysteine, thioalkanoic acid of 1 to 7 carbon atoms or ascorbic acid.
Claim 14
Dependent Claim
21 words
The composition according to Claim 10, wherein the reducing compound is in a concentrationof 0.05- 20 mg/ml as an agueous solution.
Claim 15
Dependent Claim
19 words
The composition according to Claim 1, which comprises a combination of the human serum albumin and the reducing compound.
Claim 16
Dependent Claim
27 words
The composition according to Claim 1, which further comprises an monoamino aliphatic amino acid, a cyclic amino acid, a aonosaccharide, a sugar alcohol or a combination thereof.
Claim 17
Dependent Claim
13 words
The composition according to Claim 1, which further comprises monoamino aliphatic amino acid.
Claim 18
Dependent Claim
25 words
The composition according to Claim 16, wherein the monoamino aliphatic amino acid is in a concentration of 5 to 50 mg/ml as an aqueous solution.
Claim 19
Dependent Claim
29 words
The composition according to Claim 1, wherein the composition is adjusted by an acidic reducing compound, an acidic amino acid, a mineral acid or/and a buffer of organic acid.
Claim 20
Dependent Claim
13 words
The composition according to Claim 1, wherein the pH is 3 to 5.5.
Claim 21
Dependent Claim
19 words
The composition according to Claim 1, which is in a form of an aqueous solution, frozen matter or lyophilizate.
Claim 22
Dependent Claim
13 words
The composition according to Claim 1, which is in a form of lyophilizate.
Claim 23
Independent Claim
60 words
A method of producing an interleukin-2 composition comprising human serum albumin, a reducing compound or a combination thereof and being adjusted as showing pH of 3 to 6 as a solution, which comprises incorporating human serum albumin, a reducing compound or a combination thereof into an aqueous solution of interleukin-2 and adjusting the solution as showing p H mentioned above.
Claim 24
Independent Claim
60 words
A method of producing an interleukin-2 composition comprising human serum albumin, a reducing compound or a combination thereof and being adjusted as showing pH of 3 to 6 as a solution, which comprises incorporating human serum albumin, a reducing compound or a combination thereof into an aqueous solution of interleukin-2 and adjusting the solution as showing p H mentioned above.
Claim 25
Dependent Claim
18 words
The method according to Claim 22, wherein the resulting solution is further frozen to obtain a frozen composition.
Claim 26
Dependent Claim
18 words
The method according to Claim 22, wherein the resulting solution is further lyophilized to obtain a lyophilized composition.
Claim 27
Dependent Claim
29 words
The method according to Claim 22, wherein the aqueous solution is adjusted by an acidic reducing compound, an acidic aminoacid., a mineral acid or a buffer or organic acid.
Claim 28
Dependent Claim
16 words
The method according to Claim 25, wherein the aqueous solution is adjusted by the mineral acid.
Claim 29
Dependent Claim
17 words
The method according to Claim 25, wherein the aqueous solution is adjusted by the acidic reducing compound.
Claim 30
Dependent Claim
25 words
An interleukin-2 composition according to claim 1 for use in the production of a novel type of anticancer agent or a therapeutic aqent for immunodeficiency.
References Cited (Backward Citations)
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