Methods for preparing aluminum precipitate 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.
Claims18
A method for prolonging a shelf life of an aqueous pharmaceutical composition or vaccine comprising a bacterial protein and an aluminium-salt, said method comprising:
- (a) selecting an aluminium-salt that comprises less than 700 ppm heavy metal on the basis of weight with respect to aluminium content;
- and
- (b) combining the selected aluminium-salt with the protein for preparing an aqueous composition or vaccine,
- wherein said composition or vaccine comprises less than 350 ppb heavy metal based on the weight of the composition or vaccine, and wherein the aluminium-salt is aluminium hydroxide (Al(OH)3) or aluminium phosphate (AlPO4).
A method of use of an aluminium salt comprising less than 700 ppm heavy metal on the basis of weight with respect to aluminium content, for (i) counteracting degradation of a protein in an aqueous composition or vaccine;
- and/or (ii) prolonging storage life of an aqueous composition or vaccine;
- wherein the aqueous composition or vaccine comprises the protein, a reactive compound and the aluminium-salt, wherein the reactive compound is a redox active compound, a radical building compound, and/or a stabilizing compound, and wherein said protein is a bacterial protein.
Dependencies are inferred from the claim text.