US5637456A
Expired / Lapsed
US
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Rapid test for determining the amount of functionally inactive gene in a gene therapy vector preparation
Assignee: Sanofi Aventis Deutschland GmbH
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Filing: 1995-02-17
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Granted: 1997-06-10
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Expires: 2015-02-17
Abstract
Abstract The present invention relates generally to the area of quality control for recombinant agents to be used in gene therapy. Specifically, the invention concerns an assay used to identify the percentage of defective or therapeutically inactive vector in a vector stock.
Inventors
- 👤 Jack A. Roth
- 👤 Wei Wei Zhang
- 👤 Bruno Tocque
- 👤 Laurent Bracco
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 09:59
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/02; C12Q1/18
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
112 words
A method for determining the percentage of inactive viral vectors in a sample vital vector stock, wherein at least some of the vectors in said stock carry an effector gone that encodes a product that inhibits growth of tumor cells, induces apoptosis of tumor cells or kills tumor cells, comprising the steps of: a) introducing said sample vector stock into a culture of tumor cells; b) introducing a negative control vector stock and at least one positive control vector stock into individual tumor cell cultures; and c) after a period of time, comparing the growth of the cell culture of step a) with the growth of the cell cultures of step b).
Claim 2
Independent Claim
112 words
A method for determining the percentage of inactive viral vectors in a sample vital vector stock, wherein at least some of the vectors in said stock carry an effector gone that encodes a product that inhibits growth of tumor cells, induces apoptosis of tumor cells or kills tumor cells, comprising the steps of: a) introducing said sample vector stock into a culture of tumor cells; b) introducing a negative control vector stock and at least one positive control vector stock into individual tumor cell cultures; and c) after a period of time, comparing the growth of the cell culture of step a) with the growth of the cell cultures of step b).
Claim 3
Dependent Claim
15 words
The method of claim 1, wherein said negative control vector stock encodes an indicator gene.
Claim 4
Dependent Claim
13 words
The method of claim 2, wherein said indicator gene is a luciferase gene.
Claim 5
Dependent Claim
22 words
The method of claim 1, wherein the vectors are selected from the group consisting of adenovirus, retrovirus, vaccinia virus and adeno-associated virus.
Claim 6
Dependent Claim
11 words
The method of claim 4, wherein said vectors are adenovirus vectors.
Claim 7
Dependent Claim
15 words
The method of claim 5, wherein said adenovims vectors are contained within infectious adenovims particles.
Claim 8
Dependent Claim
14 words
The method of claim 1, wherein said effector gene is a rumor suppressor gene.
Claim 9
Dependent Claim
11 words
The method of claim 1, wherein said effector gene induces apoptosis.
Claim 10
Dependent Claim
15 words
The method of claim 7, wherein said tumor suppressor gene is a wild-type p53 gene.
Claim 11
Dependent Claim
28 words
The method of claim 9, wherein said tumor cells are selected from the group consisting of lung, colon, breast, pancreas, prostate, head and neck and skin cancer cells.
Claim 12
Dependent Claim
18 words
The method of claim 1, wherein the limit of detection of said inactive vectors is greater than 0.05%.
Claim 13
Dependent Claim
16 words
The method of claim 1, wherein said period of time is between 2 to 10 days.
Claim 14
Dependent Claim
16 words
The method of claim 12, wherein said period of time is between 3 to 5 days.
Claim 15
Dependent Claim
27 words
The method of claim 1, wherein said control vector stocks comprise a percentage of inactive vectors of 0%, 0.1%, 0.5%, 1.0%, 2.0%, 5.0%, 10%, 20% or 100%.
Claim 16
Dependent Claim
30 words
A kit comprising at least one receptacle, wherein said receptacle includes a negative control vector stock, wherein at least some of the vectors in said stock carry an indicator gene.
Claim 17
Dependent Claim
30 words
A kit comprising at least one receptacle, wherein said receptacle includes a negative control vector stock, wherein at least some of the vectors in said stock carry an indicator gene.
Claim 18
Dependent Claim
18 words
The kit of claim 15, further comprising a second receptacle, said second receptacle including positive control vector stock.
Claim 19
Dependent Claim
18 words
The kit of claim 16, wherein said kit contains vector stocks comprising from 0% to 100% inactive vectors.
Claim 20
Dependent Claim
30 words
The kit of claim 17, wherein said control vector stocks comprise a percentage of vectors encoding said indicator gene of 0.1%, 0.5%, 10% 2 0% 5 0% 10% or 20%.
Claim 21
Dependent Claim
11 words
The kit of claim 15 wherein said indicator gene encodes luciferase.
Claim 22
Dependent Claim
11 words
The kit of claim 15, wherein said vectors are adenovirus vectors.
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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) | 2000-06-09 | 2000-12-09 | 2001-06-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-06-09 | 2004-12-09 | 2005-06-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-06-09 | 2008-12-09 | 2009-06-10 | $7700.00 | Window Closed / Lapsed |