Stable liquid formulation for monoclonal antibodies
AssigneeSanofi
InventorsTill BUSSEMER, Annette PIEPER, Dijana SAGI, Nina STREBE, Ahmed YOUSSEFF
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Abstract
The present invention concerns stable pharmaceutical compositions for monoclonal antibodies, for example IgG antibodies. The invention further relates to medicaments and treatments using the pharmaceutical compositions of the invention. Additionally, the invention relates to a kit comprising at least one of the pharmaceutical compositions of the invention and a method for reducing aggregation of antibodies.
Claims24
A pharmaceutical composition comprising:
- a) an antibody,
- b) at least one buffer agent selected from the group consisting of acetate and histidine,
- c) at least one amino acid selected from the group consisting of glycine, asparagine and glutamine, and/or at least one excipient selected from the group consisting of threhalose and mannitol, and
- d) a surfactant,
- wherein the pH of the composition is 5.0 to 6.5.
The composition according to claim 3, wherein the composition comprises 5 to 15 mM of at least one buffer agent that is optionally acetate or histidine.
4-5. (canceled)
(canceled)
10-12. (canceled)
24-27. (canceled)
Dependencies are inferred from the claim text.