Granted Patent
B2
US 12,286,456 · App. 17/399,731 · Granted Apr 29, 2025
Purification of virus like particles
Assignee:
Takeda Vaccines, Inc.
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Abstract
Methods of purifying virus-like particles (VLPs) that are substantially free of process contaminants and infectious agents. The methods incorporate, for example, low-pH treatment during harvest and/or inactivation by a solvent and/or detergent during VLP capture.
Claims (23)
1. A solution comprising a purified population of human norovirus Virus-Like Particles (VLPs), wherein the norovirus VLPs comprise at least genogroup II VLPs, wherein said solution contains no more than about 80% residual contaminating protein relative to said VLPs, and wherein the genogroup II VLPs comprise less than 1% VLPs with a truncated VP1 subunit.
2. The solution of claim 1 , wherein the genogroup II VLPs are genogroup II, genotype 4 VLPs.
3. The solution of claim 1 , wherein the solution contains no more than about 10% residual contaminating protein relative to VLP.
4. The solution of claim 1 , wherein the VLPs are soluble and structurally intact.
5. The solution of claim 1 , wherein the solution is suitable for use in a commercial process.
6. The solution of claim 1 , wherein the solution is derived from a cell lysate, culture supernatant, or filtrate containing the VLPs.
7. The solution of claim 6 , wherein the solution contains at least about 50%, at least about 65%, or at least about 75% of the VLPs as compared to the lysate, supernatant, or filtrate.
8. The solution of claim 6 , wherein the ratio of the VLPs to residual contaminating protein is increased at least about ten-fold, at least about fifty-fold, or at least about ninety-fold as compared to the lysate, supernatant or filtrate.
9. The solution of claim 6 , wherein the solution contains no more than about 35% residual contaminating nucleic acid relative to the lysate, supernatant, or filtrate.
10. The solution of claim 6 , wherein the solution contains no more than about 5%, no more than about 2%, or no more than about 1% residual contaminating nucleic acid relative to the lysate, supernatant, or filtrate.
11. The solution of claim 6 , wherein the lysate, supernatant, or filtrate comprises a live virus other than a human norovirus, and wherein the level of live virus in the solution is less than 10% of the level of the live virus in the lysate, supernatant, or filtrate.
12. The solution of claim 11 , wherein the level of live virus in the solution is at least about 10 4 , at least about 10 5 , at least about 10 6 , or at least about 10 7 fold less than in the lysate, supernatant, or filtrate.
13. The solution of claim 11 , wherein the live virus is a production virus, or a contaminating virus.
14. The solution of claim 11 , wherein the live virus is a production virus that was used to generate the norovirus VLPs.
15. The solution of claim 11 , wherein the virus is a rotavirus, a baculovirus, or a retrovirus.
16. A vaccine comprising the norovirus VLPs obtained from the solution of claim 1 .
17. The vaccine of claim 16 , wherein the vaccine comprises 5-200 μg of the norovirus VLPs.
18. The vaccine of claim 16 , wherein the vaccine further comprises an adjuvant.
19. The vaccine of claim 16 , wherein the vaccine further comprises aluminum hydroxide.
20. The vaccine of claim 16 , wherein the vaccine further comprises a buffer.
21. The vaccine of claim 16 , wherein the vaccine further comprises L-histidine or imidazole.
22. The vaccine of claim 16 , wherein the vaccine is formulated for parenteral administration.
23. The vaccine of claim 16 , wherein the pH of the vaccine is from about 6.0 to about 7.0.
Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 12, 2021
From: TAYLOR, ROSS
To: LIGOCYTE PHARMACEUTICALS, INC.
Reel/Frame 057158/0749 →
MERGER AND CHANGE OF NAME
Recorded Aug 12, 2021
From: TAKEDA VACCINES (MONTANA), INC.; INVIRAGEN, INC.
To: TAKEDA VACCINES INC.
Reel/Frame 057158/0913 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Aug 12, 2021
From: TAYLOR, ROSS
To: TAKEDA VACCINES (MONTANA), INC.
Reel/Frame 057159/0079 →
CHANGE OF NAME
Recorded Aug 12, 2021
From: LIGOCYTE PHARMACEUTICALS, INC.
To: TAKEDA VACCINES (MONTANA), INC.
Reel/Frame 057178/0861 →
Continuity (5)
Provisional Application
61794086
· Mar 15, 2013
Provisional Application
61663218
· Jun 22, 2012
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