Method for depleting viral and molecular pathogens in a biological material

• US 20020018985A1
• Filed: 08/20/2001
• Published: 02/14/2002
• Est. Priority Date: 06/13/1997
• Status: Active Grant

• Current Assignee: Friedrich Dorner, Gerhard Polsler, Johann Eibl, Noel Barrett
• Original Assignee: Friedrich Dorner, Gerhard Polsler, Johann Eibl, Noel Barrett
• Inventors: Polsler, Gerhard, Eibl, Johann, Dorner, Friedrich, Barrett, Noel
• Granted Patent: US 6,465,170 B2
• Time in Patent Office: Days
• US Class Current: 435/2
• CPC Class Codes: A61L 2/0011 using physical methods
• CPC Class Codes: B01J 41/20 Anion exchangers for chromatographic processes

Abstract

A method for depleting viral and molecular pathogens in a biological material containing one or several biological substances to be recovered is disclosed, wherein the biological material is admixed with an organic solvent, the solvent-admixed biological material is contacted with an ion exchanger, wherein the pathogens are adsorbed on the ion exchanger material, and at least one of the biological substances to be recovered does not interact or interacts only slightly with the ion exchanger, and the ion exchanger with the pathogens adsorbed thereon is sesparated from the biological material, a virus-depleted preparation of the biological substance being recovered.

Claims

1. A method for depleting viral and molecular pathogens in a biological material containing one or several biological substances to be recovered, characterized in that

the biological material is admixed with an organic solvent,

the solvent-admixed biological material is contacted with an ion exchanger, the pathogens being adsorbed on said ion exchanger material and at least one of the biological substances to be recovered not interacting or only slightly interacting with the ion exchanger, and

the ion exchanger with the adsorbed pathogens is spearated from the biological material, a virus-depleted preparation of the biological substance being recovered.

2. A method according to claim 1, characterized in that an anion exchanger, preferably an anion exchanger of the DEAE type, in particular DEAE-Sephadex, is used as the ion exchanger material.

3. A method according to claim 1 or 2, characterized in that the organic solvent is used at a concentration of from 5 to 20% (v/v), preferably at a concentration of from 10 to 15% (v/v), in particular at a concentration of from 12 to 14% (v/v).

4. A method according to any one of claims 1 to 3, characterized in that a mono- or polyvalent alcohol, in particular ethanol, is used as the organic solvent.

5. A method according to any one of claims 1 to 4, characterized in that incubation with the ion exchanger is effected at a temperature of below 10°

C., preferably below 5°

C., in particular between 0 and −

10°

C.

6. A method according to any one of claims 1 to 5, characterized in that incubation with the ion exchanger is effected at a pH of between 5.2 and 7.2, preferably between 6.0 and 6.4, in particular at approximately 6.2.

7. A method according to any one of claims 1 to 6, characterized in that incubation with the ion exchanger is effected f or 1 to 20 hours, preferably 4 to 8 hours, incubation being effected either in the batch method or in a continous flow system.

8. A method according to any one of claims 1 to 7, characterized in that ethanol is used as the organic solvent, preferably at a concentration of from 5 to 20%, particularly preferred from 10 to 15%, in particular from 12 to 14%.

9. A method according to any one of claims 1 to 8, characterized in that immunoglobulins or blood factors are recovered as the biological substances.

10. A method according to any one of claims 1 to 9, characterized in that separation of the ion exchanger/pathogen complex is effected by the biological material penetrating through a permeable filter.