Methods for preparing aluminum precipitate compounds for use in therapeutics and vaccines
AssigneeValneva Austria GmbH
InventorsRobert Schlegl, Michael Möhlen, Jürgen Heindl-Wruss, Michael Weber
Life of this patent
Estimating the term…
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.
Claims20
An aqueous composition comprising an inactivated Japanese Encephalitis Virus (JEV) antigen, a reactive compound, and an aluminum salt, wherein the composition is about 0.5 ml in volume which equals one dose and:
- (i) comprises less than 1.25 ppb copper (Cu);
- (ii) comprises between 0.1 mg/mL and 2.5 mg/mL aluminum;
- (iii) is buffered to a pH between 6.5 and 8.5;
- and
- (iv) wherein the aluminium salt which is aluminium hydroxide (Al(OH)3) or aluminium phosphate (AlPO4).
A method of preparing an aqueous composition comprising an inactivated Japanese Encephalitis Virus (JEV) antigen, a reactive compound, and an aluminum salt, wherein the composition is about 0.5 ml in volume which equals one dose and:
- (i) comprises less than 1.25 ppb copper (Cu);
- (ii) comprises between 0.1 mg/mL and 2.5 mg/mL aluminum;
- (iii) is buffered to a pH between 6.5 and 8.5;
- and
- (iv) comprises an aluminium salt which is is aluminium hydroxide (Al(OH)3) or aluminium phosphate (AlPO4).
A method of inducing an immune response against Japanese Encephalitis Virus (JEV) in a subject, the method comprising administrating to the subject about 0.5 ml of an aqueous composition comprising;
- (i) an inactivated Japanese Encephalitis Virus (JEV) antigen;
- and
- (ii) an aluminum salt,
- wherein the composition comprises less than about 1.25 ppb copper (Cu), contains between about 0.1 mg/mL and about 2.5 mg/mL aluminum, is buffered to a pH between about 6.5 and about 8.5, and the aluminum salt is selected from the group consisting of aluminum hydroxide (Al(OH)3) and aluminum phosphate (AlPO4).
Dependencies are inferred from the claim text.