Aluminum compounds for use in therapeutics and vaccines

Patent metadata

Field	Value
Publication number	US-9913898-B2
Application number	US-201615223027-A
Country	US
Kind code	B2
Filing date	Jul 29, 2016
Priority date	Apr 18, 2012
Publication date	Mar 13, 2018
Grant date	Mar 13, 2018

Abstract

The invention relates to means and methods for preparing aqueous composition comprising aluminum and a protein said composition comprising less than 700 ppm heavy metal on the basis of weight with respect to the aluminum content. The invention further relates to aqueous compositions comprising a protein and an aluminum-salt, said composition comprising less than 350 ppb heavy metal based on the weight of the aqueous composition.

First claim

What is claimed is:

1. An aqueous composition comprising a protein and an aluminum-salt, wherein the aluminum-salt is selected to provide an aqueous composition comprising less than 3 ppb Cu based on the weight of the aqueous composition, and wherein said protein is protein within formaldehyde inactivated virus particles.

2. The aqueous composition according to claim 1 , which has been stored at temperatures higher than 20° C. for at least 1 month.

3. The aqueous composition according to claim 1 , comprising less than 350 ppb heavy metal, wherein said heavy metal is selected from Ni, W, Co, Os, Ru, Cd, Ag, Fe, V, Cr, Pb, Rb and Mo.

4. The aqueous composition according to claim 1 , comprising less than 350 ppb heavy metal, wherein said heavy metal is selected from Ni, W, Co, Os, Ru, Cd, Ag, Fe, and V.

5. The aqueous composition according to claim 1 , comprising less than 350 ppb heavy metal, wherein said heavy metal is Ni.

6. The aqueous composition according to claim 1 , comprising less than 350 ppb heavy metal, wherein said heavy metal is present in ionic form.

7. The aqueous composition according to claim 1 , wherein the aluminum-salt is aluminum hydroxide (Al(OH) 3 ) or aluminum phosphate (AlPO 4 ).

8. The aqueous composition according to claim 1 , wherein the aluminum-salt is aluminum hydroxide (Al(OH) 3 ).

9. The aqueous composition according to claim 1 , further comprising a reactive compound selected from the group consisting of a redox active compound, a radical building compound, a stabilizing compound and a combination of any thereof.

10. The aqueous composition according to claim 1 , further comprising a reactive compound selected from the group consisting of formaldehyde, ethanol, chloroform, trichloroethylene, acetone, polyethylene glycol tert-octylphenyl ether, deoxycholate, diethylpyrocarbonate, sulphite, Na 2 S 2 O 5 , beta-proprio-lacton, polysorbate optionally Polysorbate 20 or Polysorbate 80, O 2 , phenol, pluronic type copolymers, and a combination of any thereof.

11. The aqueous composition according to claim 1 , comprising between 5 μg/ml and 50 mg/ml aluminum.

12. The aqueous composition according to claim 1 , comprising between 50 μg/ml and 5 mg/ml aluminum.

13. The aqueous composition according to claim 1 , comprising between 5 ppb and 250 ppb Fe based on the weight of the aqueous composition.

14. The aqueous composition according to claim 1 , comprising less than 40 ppb Ni based on the weight of the aqueous composition.

15. The aqueous composition according to claim 1 , wherein said protein is a therapeutic and/or a vaccine.

16. The aqueous composition according to claim 1 , further comprising sulphite.

17. A vaccine comprising the aqueous composition according to claim 1 .

18. The aqueous composition according to claim 1 , wherein said composition comprises less than 2.5 ppb Cu based on the weight of the aqueous composition.

Assignees

• Valneva Austria Gmbh

Inventors

• Schlegl Robert
• Möhlen Michael
• Wruss Jürgen
• Weber Michael

Classifications

• A61P31/12

  Antivirals · CPC title

• A61P37/04

  Immunostimulants · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• A61K39/395

  Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum · CPC title

• A61K2039/55505

  Inorganic adjuvants · CPC title