US5151266A
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US
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Use of anionic detergents with conjugates of monoclonal or polyclonal antibodies
Assignee: Poniard Pharmaceuticals Inc
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Filing: 1988-12-22
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Granted: 1992-09-29
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Expires: 2008-12-22
Abstract
Abstract Methods are disclosed for increasing the solubility of antibodies and their radioisotope, toxin, or drug immunoconjugates and for reducing the non-specific uptake of antibody, either conjugated or unconjugated, into the RES organs such as via Fc receptor-mediated mechanisms. The methods involve incubation of the reactive component with amphipathic molecules, such as an anionic detergent, to achieve the desired result. A preferred anionic detergent in this regard is sodium dodecylsulfate.
Inventors
- 👤 A. Charles Morgan, Jr.
- 👤 Gowsala Pavanasasivam
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 02:03
CPC Classifications
A; A61; A61K; A61K51/00; A61K51/02; A61K51/04; A61K51/08; A61K51/10; A61K47/00; A61K47/06; A61K47/20; A61K9/00; A61K9/0012; A61K9/0019; C; C07; C07K; C07K16/00; A61K2123/00; A61K38/00; Y; Y10; Y10S; Y10S424/00; Y10S424/804; Y10S516/00; Y10S516/01; Y10S530/00; Y10S530/827; Y10S530/828; Y10S530/861
Claims Analysis
Total Claims: 48
Claim 1
Independent Claim
47 words
A method for increasing the solubility of an immunoreactive immunoconjugate preparation without substantially affecting the immunoreactivity of the preparation, comprising: incubating the immunoreactive immunoconjugate preparation with ananionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 2
Independent Claim
47 words
A method for increasing the solubility of an immunoreactive immunoconjugate preparation without substantially affecting the immunoreactivity of the preparation, comprising: incubating the immunoreactive immunoconjugate preparation with ananionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 3
Dependent Claim
12 words
The method of claim 1 wherein said anionic detergent is sodium dodecylsulfate.
Claim 4
Dependent Claim
18 words
The method of claim 2 wherein said immunoconjugate preparation is present in a concentration of approximately 1 mg/ml.
Claim 5
Dependent Claim
14 words
The method of claim 2 wherein said immunoconjugate preparation is incubated for 30-60 minutes.
Claim 6
Dependent Claim
19 words
The method of claim 4 wherein the step of incubation is carried out at 25° C. or 37° C.
Claim 7
Dependent Claim
23 words
The method of claim 2 wherein the step of incubation is carried out at 37° C. for a period of approximately 30 minutes.
Claim 8
Dependent Claim
23 words
The method of claim 2 wherein the step of incubation is carried out at 25° C. for a period of approximately one hour.
Claim 9
Dependent Claim
25 words
The method of claim 2 including, after the step of incubating, removing the non-antibody bound SDS by crystallization, gel filtration or by passage over albumin/Sepharose.
Claim 10
Dependent Claim
15 words
The method of claim 3 wherein said detergent is present in a concentration of 0.1%.
Claim 11
Dependent Claim
15 words
The method of claim 3 wherein said detergent is present in a concentration of 0.5%.
Claim 12
Dependent Claim
27 words
The method of claim 3 wherein said anionic detergent is selected from the group consisting of alkyl sulfates, alkyl aryl sulfates, alkyl aryl sulfonates and alkyl sarcosinates.
Claim 13
Independent Claim
49 words
A method for increasing the solubility of an unconjugated immunoreactive immunoglobulin preparation without substantially affecting the immunoreactivity of the preparation, comprising: incubating the immunoreactive immunoglobin preparation with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 14
Independent Claim
49 words
A method for increasing the solubility of an unconjugated immunoreactive immunoglobulin preparation without substantially affecting the immunoreactivity of the preparation, comprising: incubating the immunoreactive immunoglobin preparation with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 15
Dependent Claim
12 words
The method of claim 11 wherein said anionic detergent is sodium dodecylsulfate.
Claim 16
Dependent Claim
14 words
The method of claim 13 wherein said immunoglobin preparation is incubated for 30-60 minutes.
Claim 17
Dependent Claim
19 words
The method of claim 14 wherein the step of incubation is carried out at 25° C. or 37° C.
Claim 18
Dependent Claim
15 words
The method of claim 13 wherein said detergent is present in a concentration of 0.1%.
Claim 19
Dependent Claim
15 words
The method of claim 13 wherein said detergent is present in a concentration of 0.5%.
Claim 20
Dependent Claim
27 words
The method of claim 13 wherein said anionic detergent is selected from the group consisting of alkyl sulfates, alkyl aryl sulfates, alkyl aryl sulfonates and alkyl sarcosinates.
Claim 21
Dependent Claim
18 words
The method of claim 12 wherein said immunoglobulin preparation is a member of the subclass IgG 3 .
Claim 22
Independent Claim
64 words
A method for reducing the capability of an immunoreactive antibody, or an immunoreactive antibody conjugate, to bind to a nonspecific receptor without substantially affecting the immunoreactivity of the antibody or antibody conjugate, comprising: incubating the immunoreactive antibody or immunoreactive antibody conjugate with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 23
Independent Claim
64 words
A method for reducing the capability of an immunoreactive antibody, or an immunoreactive antibody conjugate, to bind to a nonspecific receptor without substantially affecting the immunoreactivity of the antibody or antibody conjugate, comprising: incubating the immunoreactive antibody or immunoreactive antibody conjugate with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anionic detergent.
Claim 24
Dependent Claim
12 words
The method of claim 18 wherein said anionic detergent is sodium dodecylsulfate.
Claim 25
Dependent Claim
16 words
The method of claim 20 wherein said antibody or antibody conjugate is incubated for 30-60 minutes.
Claim 26
Dependent Claim
19 words
The method of claim 22 wherein the step of incubation is carried out at 25° C. or 37° C.
Claim 27
Dependent Claim
15 words
The method of claim 21 wherein said detergent is present in a concentration of 0.1%.
Claim 28
Dependent Claim
15 words
The method of claim 21 wherein said detergent is present in a concentration of 0.5%.
Claim 29
Dependent Claim
27 words
The method of claim 21 wherein said anionic detergent is selected from the group consisting of alkyl sulfates, alkyl aryl sulfates, alkyl aryl sulfonates and alkyl sarcosinates.
Claim 30
Dependent Claim
29 words
The method of claim 20 wherein the receptor is selected from the group consisting of Fc receptors, C3b receptors, C3d receptors, immune complex receptors, carbohydrate receptors and glycoprotein receptors.
Claim 31
Independent Claim
38 words
A method for reducing the toxicity of intact toxin conjugates, comprising: incubating the toxin conjugate with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anioinic detergent.
Claim 32
Independent Claim
38 words
A method for reducing the toxicity of intact toxin conjugates, comprising: incubating the toxin conjugate with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anioinic detergent.
Claim 33
Dependent Claim
12 words
The method of claim 25 wherein said anionic detergent is sodium dodecylsulfate.
Claim 34
Dependent Claim
14 words
The method of claim 27 wherein said toxin conjugates are incubated for 30-60 minutes.
Claim 35
Dependent Claim
19 words
The method of claim 30 wherein the step of incubation is carried out at 25° C. or 37° C.
Claim 36
Dependent Claim
15 words
The method of claim 29 wherein said detergent is present in a concentration of 0.1%.
Claim 37
Dependent Claim
15 words
The method of claim 29 wherein said detergent is present in a concentration of 0.5%.
Claim 38
Dependent Claim
27 words
The method of claim 29 wherein said anionic detergent is selected from the group consisting of alkyl sulfates, alkyl aryl sulfates, alkyl aryl sulfonates and alkyl sarcosinates.
Claim 39
Dependent Claim
11 words
The method of claim 28 wherein the intact toxin is abrin.
Claim 40
Independent Claim
40 words
A method for reducing the level of endotoxin activity in biological preparations, comprising: incubating the biological preparation with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anioinic detergent.
Claim 41
Independent Claim
40 words
A method for reducing the level of endotoxin activity in biological preparations, comprising: incubating the biological preparation with an anionic detergent at a concentration between about 0.01% and 1% by weight to volume; and removing substantially any unbound anioinic detergent.
Claim 42
Dependent Claim
12 words
The method of claim 31 wherein said anionic detergent is sodium dodecylsulfate.
Claim 43
Dependent Claim
15 words
The method of claim 33 wherein said monoclonal antibody preparation is incubated for 30-60 minutes.
Claim 44
Dependent Claim
19 words
The method of claim 38 wherein the step of incubation is carried out at 25° C. or 37° C.
Claim 45
Dependent Claim
15 words
The method of claim 37 wherein said detergent is present in a concentration of 0.1%.
Claim 46
Dependent Claim
15 words
The method of claim 37 wherein said detergent is present in a concentration of 0.5%.
Claim 47
Dependent Claim
27 words
The method of claim 37 wherein said anionic detergent is selected from the group consisting of alkyl sulfates, alkyl aryl sulfates, alkyl aryl sulfonates and alkyl sarcosinates.
Claim 48
Dependent Claim
30 words
The method of claim 31 wherein said biological preparation is a monoclonal antibody preparation purified from ascites of BALB/c mice or from monoclonal antibody grown in large scale tissue culture.
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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) | 1995-09-29 | 1996-03-30 | 1996-09-29 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-09-29 | 2000-03-30 | 2000-09-29 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-09-29 | 2004-03-30 | 2004-09-29 | $7700.00 | Window Closed / Lapsed |