EP0292003A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Stabilzation of biological and pharmaceutical products during inactivation of viral and bacterial contaminants
Assignee: Armour Pharmaceutical Co
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Filing: 1988-05-20
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Granted: —
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Expires: 2008-05-20
Abstract
Abstract A method of inactivating pathogens in a biological or a pharmaceutical material comprising the steps of: mixing the material in an aqueous solution containing at least one primary stabilizer selected from sugars or sugar alcohols and at least one secondary stabilizer selected from the group consisting of neutral salts; adjusting the pH of the aqueous solution to about 5.0 to 10.0; subjecting the aqueous solution to a pathogen inactivating process; and optionally removing the primary and secondary stabilizers from the aqueous solution.
Inventors
- 👤 Fred Feldman
- 👤 Mark S. Klekamp
- 👤 Michael E. Hrinda
- 👤 Arthur B. Shaw
- 👤 Sudhish Chandra
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-03 09:05
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/02; A61L2/04; A61P; A61P7/00; A61P7/04; A61L2103/00; A61L2103/05
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
82 words
A method of inactivating pathogens in a biological or a pharmaceutical material comprising the steps of: mixing the material in an aqueous solution containing at least one primary stabilizer selected from sugars or sugar alcohols and at least one secondary stabilizer selected from the group consisting of neutral salts; adjusting the pH of the aqueous solution to about 5.0 to 10.0; subjecting the aqueous solution to a pathogen inactivating process; and optionally removing the primary and secondary stabilizers from the aqueous solution.
Claim 2
Independent Claim
82 words
A method of inactivating pathogens in a biological or a pharmaceutical material comprising the steps of: mixing the material in an aqueous solution containing at least one primary stabilizer selected from sugars or sugar alcohols and at least one secondary stabilizer selected from the group consisting of neutral salts; adjusting the pH of the aqueous solution to about 5.0 to 10.0; subjecting the aqueous solution to a pathogen inactivating process; and optionally removing the primary and secondary stabilizers from the aqueous solution.
Claim 3
Dependent Claim
29 words
The method of Claim 1 wherein the pathogen inactivating process comprises subjecting said aqueous solution to a temperature of 30°C. to 100°C. for about 1 minute to 72 hours.
Claim 4
Dependent Claim
15 words
The method of Claim 1 wherein the pathogen inactivating process comprises chemical inactivation or irradiation.
Claim 5
Dependent Claim
33 words
The method of Claim 1 wherein the pH of the aqueous solution is adjusted to about 6.7 to about 7.7 and the solution is subjected to pasteurization conditions sufficient to deactivate pathogens therein.
Claim 6
Dependent Claim
24 words
The method of Claim 4 wherein the pasteurization is carried out at a temperature of about 55°C. to 70°C. for 10 to 20 hours.
Claim 7
Independent Claim
18 words
The method of any of Claims 1 to 5 wherein the primary stabilizer is a mono-, di-, tri-saccharide.
Claim 8
Dependent Claim
24 words
The method of Claim 6 wherein the sugars are glucose, sucrose, xylose, fructose, mannitol, and said sugar alcohols are galactitol, glucosaminitol, sorbitol or galactosaminitol.
Claim 9
Independent Claim
23 words
The method of any of Claims 1 to 7 wherein the primary stabilizer is present at a concentration from 10% w/v to saturation.
Claim 10
Dependent Claim
20 words
The method of Claim 8 wherein the stabilizer is sucrose at a concentration of about 50% w/v to 70% w/v.
Claim 11
Independent Claim
37 words
The method of any of Claims 1 to 9 wherein the secondary stabilizer is sodium acetate, potassium acetate, sodium sulfate, ammonium sulfate, lithium sulfate, potassium sulfate, magnesium sulfate, barium sulfate, lithium acetate, magnesium acetate or barium acetate.
Claim 12
Dependent Claim
21 words
The method of Claim 10 wherein the secondary stabilizer is sodium acetate at a concentration of about 0.5M to about 2.5M.
Claim 13
Independent Claim
25 words
The method of any of Claims 1 to 11 wherein removal of primary and secondary stabilizers is by diafiltration, dialysis, column chromatography or by precipitation.
Claim 14
Independent Claim
14 words
The method of any of Claims 1 to 12 wherein said material is proteinaceous.
Claim 15
Independent Claim
35 words
The method of any of Claims 1 to 13 wherein said material is in a processing stage of the finished product, the finished product, an active compound in the finished product or the finished product.
Claim 16
Independent Claim
18 words
The method of any of Claims 1 to 14 wherein said material is Factor VIII or prothombin complex.
Claim 17
Dependent Claim
27 words
A proteinaceous product having been treated at any desired stage of its production by a method which comprises the method of any of Claims 1 to 15.
References Cited (Backward Citations)
No citation records indexed.
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