Methods for preparing aluminum precipitate compounds for use in therapeutics and vaccines

Patent metadata

Field	Value
Publication number	US-10668146-B2
Application number	US-201715469689-A
Country	US
Kind code	B2
Filing date	Mar 27, 2017
Priority date	Apr 18, 2012
Publication date	Jun 2, 2020
Grant date	Jun 2, 2020

Abstract

The invention relates to means and methods for preparing aqueous composition comprising aluminium and a protein said composition comprising less than 700 ppm heavy metal on the basis of weight with respect to the aluminium content. The invention further relates to aqueous compositions comprising a protein and an aluminium-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. A method for preparing a clinical grade aluminum salt precipitate for incorporation into a medicament and/or vaccine, said method comprising
preparing an aqueous solution of aluminum ions and precipitating said aluminum-ions from said solution to form an aluminum salt precipitate, and
determining the level of copper (Cu) in the solution and/or the aluminum salt precipitate, wherein the precipitate is selected that is able to provide an aqueous composition comprising less than 3 ppb Cu based on the weight of the aqueous composition.

2. The method of claim 1 , wherein the precipitate is selected that is able to provide an aqueous composition comprising less than 2.5 ppb Cu based on the weight of the aqueous composition.

3. The method of claim 2 , wherein the precipitate is selected that is able to provide an aqueous composition comprising less than 1.25 ppb Cu based on the weight of the aqueous composition.

4. The method of claim 2 , further comprising determining the level of nickel (Ni) in the solution and/or the aluminum salt precipitate, wherein the precipitate is selected that is able to provide an aqueous composition comprising less than 40 ppb Ni based on the weight of the aqueous composition.

5. A method for manufacture of a medicine, comprising
selecting an aluminium hydroxide concentrate that comprises less than 3.0 ppb Cu based on the weight of the medicine; and
preparing the medicine using the aluminium hydroxide concentrate.

6. The method of claim 5 , wherein the aluminium hydroxide concentrate comprises less than 2.5 ppb Cu based on the weight of the medicine.

7. The method of claim 6 , wherein the aluminium hydroxide concentrate comprises less than 1.25 ppb Cu based on the weight of the medicine.

8. The method of claim 5 , wherein the medicine is a vaccine.

9. The method of claim 5 , wherein the aluminium hydroxide concentrate comprises 10 mg/ml of aluminium hydroxide.

10. The method of claim 5 , wherein the aluminium hydroxide concentrate comprises between 5 ppb and 250 ppb iron (Fe) based on the weight of the medicine.

11. The method of claim 5 , wherein the aluminium hydroxide concentrate comprises less than 40 ppb nickel (Ni) based on the weight of the medicine.

12. The method of claim 2 , further comprising determining the level of iron (Fe) in the solution and/or the aluminum salt precipitate, wherein the precipitate is selected that is able to provide an aqueous composition comprising between 5 ppb and 250 ppb Fe based on the weight of the aqueous composition.

Assignees

• Valneva Austria Gmbh

Inventors

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

Classifications

• A61K38/164

  from bacteria · CPC title

• A61K39/12

  Viral antigens · CPC title

• A61K39/39 Primary

  characterised by the immunostimulating additives, e.g. chemical adjuvants · CPC title

• C12N7/00

  Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title

• A61K2039/70

  Multivalent vaccine · CPC title