US5076933A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Process and apparatus for removal of dna and viruses
Assignee: Beckman Coulter Inc
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Filing: 1990-06-29
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Granted: 1991-12-31
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Expires: 2010-06-29
Abstract
Abstract A single filtration device containing coated filter membranes and absolute pore filters is provided in which the membranes and absolute pore filters are present in two sections of the filter device. The filter device will remove viruses, as modeled by type-C Xenotropic retrovirus, with an efficiency of at least 4.6×10 5 ; remove DNA from levels of 10 μg/sample to levels below 10 picograms per 500 mg sample of monoclonal antibody; and will remove at least 97% of some bacterial endotoxins.
Inventors
- 👤 Stephan D. Glenn
- 👤 Edward O'Connell
- 👤 Paulette Smariga
- 👤 Gregory Butchko
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-09 00:34
CPC Classifications
B; B01; B01D; B01D67/00; B01D67/0081; B01D67/0088; A; A61; A61L; A61L2/00; A61L2/02; A61L2/022; B01D61/00; B01D61/14; B01D61/147; B01D61/1471; B01D61/18; B01D71/00; B01D71/06; B01D71/08; B01D71/10; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
152 words
A process for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions comprising, passing one of said aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions through a first DNA filter section and a second virus filter section, wherein said DNA, viruses and endotoxins are substantially removed; and collecting said aqueous buffer solutions, aqueous pharmaceutical solutions or aqueous biological pharmaceutical solutions; said first DNA filter having: (i) a first absolute pore filter, (ii) a first and second filter selected from one of (a) a DEAE cellulose filter membrane and (b) an absolute pore filter coated with at least one of DEAE cellulose, quaternary aminoethyl salts and quaternary aminomethyl salts, and (iii) a second absolute pore filter; and said second virus filter section having absolute pore filters of smaller pore diameter than the absolute pore filters in the DNA filter section.
Claim 2
Dependent Claim
152 words
A process for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions comprising, passing one of said aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions through a first DNA filter section and a second virus filter section, wherein said DNA, viruses and endotoxins are substantially removed; and collecting said aqueous buffer solutions, aqueous pharmaceutical solutions or aqueous biological pharmaceutical solutions; said first DNA filter having: (i) a first absolute pore filter, (ii) a first and second filter selected from one of (a) a DEAE cellulose filter membrane and (b) an absolute pore filter coated with at least one of DEAE cellulose, quaternary aminoethyl salts and quaternary aminomethyl salts, and (iii) a second absolute pore filter; and said second virus filter section having absolute pore filters of smaller pore diameter than the absolute pore filters in the DNA filter section.
Claim 3
Dependent Claim
28 words
A process in accordance with claim 1 wherein the yield of pharmaceuticals, or biological pharmaceuticals in the filtered solutions is 90% or higher compared to the starting solution.
Claim 4
Dependent Claim
46 words
A process in accordance with claim 1 wherein the virus removal is 99.9999997% or higher when the virus is 0.100 microns or larger, and the yield of pharmaceutical or biological pharmaceutical in the filtered solution of same is 90% or higher compared to the starting solution.
Claim 5
Dependent Claim
24 words
A process in accordance with claim 1 wherein said DNA in the filtered solutions is less than 10 picograms per 100 ml of solution.
Claim 6
Dependent Claim
30 words
A process in accordance with claim 1 wherein the aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions have a pH in the range of 3 to 9.
Claim 7
Dependent Claim
61 words
A process in accordance with claim 1 wherein the aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions each have a specific salt content of less than 0.5 Molar, said specific salt being at least one selected from the group consisting of the lithium, sodium, potassium and ammonium salts of the phosphate, chloride, bromide, iodide, sulfate and acetate anions.
Claim 8
Dependent Claim
24 words
A process in accordance with claim 1 wherein said DNA in the filtered solutions is less than 1 picogram per 100 ml of solution.
Claim 9
Dependent Claim
136 words
A process for the removal of DNA and viruses from aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, comprising passing either one of the solutions through a first DNA filter section and a second virus filter section to obtain a filtered aqueous pharmaceutical solution or a filtered aqueous biological pharmaceutical solution having substantially reduced DNA and virus levels, said solutions passing through: (a) a first DNA filter section comprising a first 0.2 micron absolute pore filter, a first diethylaminoethyl cellulose filter, a second diethylaminoethyl cellulose filter and a second 0.2 micron absolute pore filter, and (b) a second virus filter section comprising a first 0.1 micron absolute pore filter, a second 0.1 micron absolute pore filter, a first 0.04 micron absolute pore filter and a second 0.04 micron absolute pore filter; and collecting the filtered solutions.
Claim 10
Dependent Claim
136 words
A process for the removal of DNA and viruses from aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, comprising passing either one of the solutions through a first DNA filter section and a second virus filter section to obtain a filtered aqueous pharmaceutical solution or a filtered aqueous biological pharmaceutical solution having substantially reduced DNA and virus levels, said solutions passing through: (a) a first DNA filter section comprising a first 0.2 micron absolute pore filter, a first diethylaminoethyl cellulose filter, a second diethylaminoethyl cellulose filter and a second 0.2 micron absolute pore filter, and (b) a second virus filter section comprising a first 0.1 micron absolute pore filter, a second 0.1 micron absolute pore filter, a first 0.04 micron absolute pore filter and a second 0.04 micron absolute pore filter; and collecting the filtered solutions.
Claim 11
Dependent Claim
24 words
A process in accordance with claim 8 wherein the yield of the pharmaceutical or biological pharmaceutical, in the filtered solution is 90% or higher.
Claim 12
Dependent Claim
39 words
A process in accordance with claim 8 wherein the virus removal is 99.99999997% or when the virus is 0.100 microns or larger, and the yield of the pharmaceutical or biological pharmaceutical in the filtered solution is 90% or higher.
Claim 13
Dependent Claim
30 words
A process in accordance with claim 8 wherein the DNA in the filtered pharmaceutical or biological pharmaceutical solution is reduced to less than 10 picograms per 100 ml of solution.
Claim 14
Dependent Claim
24 words
A process in accordance with claim 8 wherein the pharmaceutical solution or biological solution has a pH in the range of 6 to 8.
Claim 15
Dependent Claim
59 words
A process in accordance with claim 8 wherein the pharmaceutical or biological pharmaceutical has a specific salt content, excluding salts of pharmaceuticals or biological pharmaceuticals, of less than 0.5 Molar, said specific salts being at least one selected from the group consisting the lithium, sodium, potassium and ammonium salts of the phosphate, chloride, bromide, iodide, sulfate and acetate anions.
Claim 16
Dependent Claim
30 words
A process in accordance with claim 8 wherein the DNA in the filtered pharmaceutical or biological pharmaceutical solution is reduced to less than 1 picogram per 100 ml of solution.
Claim 17
Dependent Claim
42 words
A process in accordance with claim 1 or 8 wherein said aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions are passed through said DNA filter section and said virus filter section by a vacuum means or a pressure means.
Claim 18
Dependent Claim
117 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, a first diethylaminoethyl cellulose filter, a second diethylaminoethyl cellulose filter and a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact.
Claim 19
Dependent Claim
117 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, a first diethylaminoethyl cellulose filter, a second diethylaminoethyl cellulose filter and a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact.
Claim 20
Dependent Claim
19 words
An improved apparatus in accordance with claim 16 wherein said 0.2, 0.1 and 0.04 filters are absolute pore filters.
Claim 21
Dependent Claim
29 words
The improved apparatus in accordance with claim 16 wherein said apparatus is capable of removing DNA to a level of less than 10 picograms per 100 ml of solution.
Claim 22
Dependent Claim
24 words
The improved apparatus of claim 16 wherein said apparatus is capable of removing 99.9999997% of virus when the virus is 0.100 microns or larger.
Claim 23
Dependent Claim
30 words
The improved apparatus of claim 16 wherein the apparatus gives a yield of pharmaceutical or biological pharmaceutical in the filtered solution of 90% or higher compared to the unfiltered solution.
Claim 24
Dependent Claim
22 words
The improved apparatus of claim 16 where the solution to be filtered is passed through said apparatus by pressure or vacuum means.
Claim 25
Dependent Claim
39 words
The improved apparatus of claim 16 wherein said apparatus is a means of administration of said aqueous buffer solution, aqueous pharmaceutical solution or aqueous biological pharmaceutical solution to a patient which means contains said DNA and virus filter sections.
Claim 26
Dependent Claim
21 words
The improved apparatus of claim 16 wherein said apparatus is a syringe filtration device containing said DNA and virus removal filters.
Claim 27
Dependent Claim
28 words
The improved apparatus in accordance with claim 14, wherein said apparatus is capable of removing DNA to a level of less than 1 picogram per ml of solution.
Claim 28
Dependent Claim
134 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means, internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact; wherein at least one of the absolute pore filters is coated with at least one of the group consisting of DEAE, QAE, QAM and other quaternary ammonium salts.
Claim 29
Dependent Claim
134 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means, internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact; wherein at least one of the absolute pore filters is coated with at least one of the group consisting of DEAE, QAE, QAM and other quaternary ammonium salts.
Claim 30
Dependent Claim
132 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means, internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, first and second absolute pore filters coated with at least one selected from the group consisting of DEAE cellulose, QAE, QAM and other quaternary ammonium salts, a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact.
Claim 31
Dependent Claim
132 words
An improved apparatus for the removal of DNA, endotoxins and viruses from aqueous buffer solutions, aqueous pharmaceutical solutions and aqueous biological pharmaceutical solutions, said apparatus having a housing with suitable inlet/outlet means, internal gaskets and filter supports, and internal filters wherein the improvement comprises a first DNA filter section having, from inflow to outflow, a first 0.2 micron filter, first and second absolute pore filters coated with at least one selected from the group consisting of DEAE cellulose, QAE, QAM and other quaternary ammonium salts, a second 0.2 micron filter, the filters having face-to-face contact; and a second virus filter section having, from inflow to outflow, a first 0.1 micron filter, a second 0.1 micron filter, a first 0.04 micron filter and a second 0.04 micron filter, said filters having face-to-face contact.
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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) | 1994-12-30 | 1995-07-01 | 1995-12-31 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-12-30 | 1999-07-01 | 1999-12-31 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-12-30 | 2003-07-01 | 2003-12-31 | $7700.00 | Window Closed / Lapsed |