EP0443724A1
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EP
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Viral-safe purified human thrombin
Assignee: Baxter International Inc
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Filing: 1991-01-24
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Granted: —
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Expires: 2011-01-24
Abstract
Abstract A viral-safe highly purified human thrombin is prepared by a commercial-scale process utilizing antiviral agents integral to a purification scheme employing ion exchange mass capture and S-sepharose affinity chromotography. The resultant thrombin product is therapeutically acceptable for human administrations.
Inventors
- 👤 Henry S. Kingdon
- 👤 Michal J. Griffith
- 👤 Joyce Lawrence
- 👤 Roger L. Lundblad
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-25 05:42
CPC Classifications
C; C12; C12N; C12N9/00; C12N9/14; C12N9/48; C12N9/50; C12N9/64; C12N9/6421; C12N9/6424; C12N9/6429; A; A61; A61L; A61L2/00; A61L2/16; A61P; A61P7/00; A61P7/04; C12Y; C12Y304/00; C12Y304/21; C12Y304/21005; A61K; A61K38/00; A61L2103/00; A61L2103/05; A61L2103/09
Claims Analysis
Total Claims: 8
Claim 1
Independent Claim
51 words
A substantially stable therapeutic-grade human thrombin in a therapeutically effective quantity, a) being substantially viral-safe; b) having a total nucleic acid content of less than 10 pg per therapeutic dose; c) being substantially homogeneous; d) being substantially nonpyrogenic; and e) having a specific activity of greater than 2200 NIH units/mg protein.
Claim 2
Dependent Claim
56 words
A substantially stable therapeutic-grade human thrombin derived from cryopoor plasma after conversion from prothrombin, said thrombin a) being substantially virus-safe; b) having a total nucleic acid content of less than 10 pg per therapeutic dose; c) being substantially homogeneous; d) being substantially nonpyrogenic; and e) having a specific activity of greater than 2200 NIH units/mg protein.
Claim 3
Dependent Claim
81 words
A substantially stable therapeutic-grade human thrombin obtained according to a process comprising: a) incubating a partially purified prothrombin complex eluted from a first mass capture means with thromboplastin in the presence of calcium ions, phospholipids and a plasmin inhibitor; b) futher incubating in the presence of a viricidal agent; c) sorbing onto a second mass capture means and washing with a physiologically compatible buffer; and d) eluting the thrombin from the second mass capture means with a second physiologcally compatible buffer.
Claim 4
Dependent Claim
14 words
The thrombin of Claim 3 wherein said plasmin inhibitor is transexamic or 6-aminohexamine acid.
Claim 5
Dependent Claim
16 words
The thrombin of Claim 3 wherein said second mass capture means is a sulfoalkyl cross-linked agarose.
Claim 6
Dependent Claim
19 words
The thrombin of Claim 3 wherein said second physiologcially compatible buffer contains L-histidine or imidazole as the buffering agent.
Claim 7
Dependent Claim
80 words
A process for production of a substantially stable therapeutic-grade human thrombin comprising: a) incubating a partially purified prothrombin complex eluted from a first mass capture means with thromboplastin in the presence of calcium ions, phospholipids and a plasmin inhibitor; b) futher incubating in the presence of a viricidal agent; c) sorbing onto a second capture means and washing with a physiologically compatible buffer; and d) eluting the thrombin from the second mass capture means with a second physioloigcally compatible buffer.
Claim 8
Dependent Claim
124 words
A therapeutic grade thrombin, said thrombin a) being substantially homogeneous when analyzed by SDS polyacrylamide gel electrophoresis, C₃-HPLC chromatograph, and immunodiffusion; b) having a total nucleic acid content of less than 10 pg per therapeutic dose; c) being contaminated by blood coagulation Factors VII, IX and X of less than 1 percent by weight in the aggregate; d) having a level of inactivated prothrombin of less than 0.1 percent; e) having a level of inactive prothrombin fragments of less than 5.0 percent; f) having a specific activity ranging minimally from 2200 NIH units per mg protein to about 3200 NIH units per mg protein; g) having a residual viricidal agent content of less than 50 ppm; and h) being substantially free of envelop viruses.
References Cited (Backward Citations)
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