Viral inactivated biological mixture

Patent metadata

Field	Value
Publication number	US-9867852-B2
Application number	US-201314134033-A
Country	US
Kind code	B2
Filing date	Dec 19, 2013
Priority date	Dec 20, 2012
Publication date	Jan 16, 2018
Grant date	Jan 16, 2018

Abstract

The invention relates to a viral inactivated biological liquid or dry mixture and to its preparation. Principally, the invention relates, but is not limited, to a mixture derived from a platelet source.

First claim

What is claimed is:

1. A method for preparing a viral-safe biological liquid mixture composition from a biological source, the method comprising the following steps:
providing the source as a clear solution;
providing a non-toxic amphiphilic polymer;
treating the source with a solvent detergent (S/D) to allow viral inactivation;
treating the source with the amphiphilic polymer at a final concentration of 0.01 to 0.9 mM wherein the clarity of the solution is maintained;
removing the S/D by contacting the treated source with an hydrophobic interaction chromatography (HIC) resin; and
collecting a material comprising an unbound fraction from HIC;
wherein the method comprises at least one more orthogonal viral inactivation treatment, thereby obtaining the viral-safe biological liquid mixture composition.

2. The method according to claim 1 , wherein removing the S/D omits a further step of oil extraction.

3. The method according to claim 1 , wherein the HIC resin is packed in a column.

4. The method according to claim 1 , wherein the source comprises cells, cell particles and/or cell organelles.

5. The method according to claim 1 , wherein the source is a blood buffy coat.

6. The method according to claim 1 , wherein the source comprises platelets.

7. The method according to claim 1 , wherein the source is a platelet-enriched fraction pooled from multiple donors.

8. The method according to claim 1 , wherein the amphiphilic polymer is a hydrocarbon based surfactant.

9. The method according to claim 1 , wherein the amphiphilic polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), hydroxy propylmethylcellulose (HPMC), and a combination thereof.

10. The method according to claim 9 , wherein the source is contacted first with the S/D and then with the PVP and wherein the PVP concentration in the S/D treated source is in the range of about 0.01 to 0.3 mM.

11. The method according to claim 9 , wherein the source is contacted first with the S/D and then with the PVP and wherein the PVP concentration in the S/D treated source is in the range of about 0.025 to 0.3 mM.

12. The method according to claim 9 , wherein the source is contacted first with the S/D and then with the HPMC and wherein the HPMC concentration in the S/D treated source is in the range of about 0.01 to 0.3 mM.

13. The method according to claim 1 , wherein the source is contacted first with the S/D and then with the amphiphilic polymer.

14. The method according to claim 1 , wherein the method further comprises the steps of: washing the resin with a solution comprising an organic solvent and/or a salt; collecting a fraction obtained following the washing step and combining with the unbound fraction.

15. The method according to claim 14 , wherein the organic solvent is ethanol.

16. The method according to claim 14 , wherein the salt is NaCL.

17. The method according to claim 1 , wherein the at least one more orthogonal viral inactivation treatment comprises heat inactivation.

18. The method according to claim 1 , further comprising a step of concentrating the material.

19. The method according to claim 1 , further comprising a step of drying the material, thereby resulting in a viral-safe biological dry mixture.

20. A method for preparing a biological liquid mixture composition from a biological source, the method comprising the following steps:
providing the source as a clear solution;
providing PVP and/or HPMC;
treating the source with a solvent detergent (S/D) to allow viral inactivation;
treating the source with the PVP and/or HPMC at a final concentration of 0.01 to 0.9 mM wherein the clarity of the solution is maintained;
removing the S/D by contacting the treated source with an hydrophobic interaction chromatography (HIC) resin; and
collecting a material comprising an unbound fraction from HIC.

21. A method for removing solvent-detergent (S/D) from a biological source comprising S/D, the method comprises the steps of:
providing the source as a clear solution;
providing an amphiphilic polymer;
treating the source with S/D and with the amphiphilic polymer at a final concentration of 0.01 to 0.9 mM wherein the clarity of the solution is maintained;
removing the S/D from the biological source by contacting the treated source with an hydrophobic interaction chromatography (HIC) resin; and
collecting a material comprising an unbound fraction from HIC.

22. The method according to claim 21 , wherein removing the S/D omits a further step of oil extraction.

Assignees

• Omrix Biopharmaceuticals Ltd

Inventors

• Weissman Lior
• Podoler Itai
• Nur Israel
• Byk-Tennenbaum Tamara

Classifications

• A61L2103/09

  Blood or products thereof · CPC title

• A61L2/18 Primary

  Liquid substances · CPC title

• A61L2103/05

  Living organisms or biological materials · CPC title

• A61L2202/22

  Human Necessities · mapped topic

• A61L2/0005

  Human Necessities · mapped topic