Aluminum compounds for use in therapeutics and vaccines
AssigneeValneva Austria GmbH
InventorsRobert Schlegl, Michael Möhlen, Jürgen Heindl-Wruss, Michael Weber
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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 pharmaceutical composition or vaccine, comprising a protein and an aluminum salt, and wherein said aqueous pharmaceutical composition comprises less than 3 ppb copper (Cu) based on the weight of the composition.
An aqueous pharmaceutical composition or vaccine comprising a protein and an aluminum salt, wherein said aqueous pharmaceutical composition comprises less than 350 ppb heavy metal based on the weight of the composition, wherein the heavy metal is selected from copper (Cu), nickel (Ni), tungsten (W), cobalt (Co), osmium (Os), ruthenium (Ru), cadmium (Cd), silver (Ag), iron (Fe), vanadium (V), chromium (Cr), lead (Pb), rubidium (Rb), and molybdenum (Mo).
An aqueous pharmaceutical composition or vaccine comprising a protein and an aluminum salt obtainable by the method comprising:
- a) preparing an aluminum salt precipitate,
- b) determining the level of copper (Cu) in the aluminum salt precipitate, and
- c) combining said aluminum salt precipitate, the protein, and water to produce said aqueous composition, wherein the aluminum salt provides an aqueous composition having less than 3 ppb Cu based on the weight of the composition.
Dependencies are inferred from the claim text.