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US 2026/0007744 A1Published application
Stable aqueous formulations for antibodies
AssigneeInnate Pharma
InventorsThibault Barbier, Angélique Boedec-Herbette, Laetitia Cohen-Tannoudji
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Abstract
The present disclosure relates to a stable aqueous formulation. The stable aqueous formulation may be used for an anti-KIR3DL2 antibody.
Claims37
A stable aqueous pharmaceutical formulation comprising:
- (i) an anti-KIR3DL2 antibody that binds to a KIR3DL2 receptor;
- (ii) one or more buffers;
- (iii) a tonicity agent;
- and
- (iv) a non-ionic surfactant;
- wherein the ratio of the antibody concentration to non-ionic surfactant is about 20:0.1 to 40:0.4.
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A method of reducing stress-induced particle formation or aggregation during drug pooling comprising:
- mixing a non-ionic surfactant with a stored antibody formulation to provide a stabilized antibody formulation comprising a ratio of antibody to non-ionic surfactant of 20:0.1 to 40:0.4;
- the antibody formulation having been stored for at least 6 months;
- whereby the stabilized antibody formulation comprises a reduced amount of particles or aggregated antibody after pooling than the stored antibody formulation after pooling with no additional non-ionic surfactant.
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A method of treating comprising:
- administering to a subject in need thereof an effective amount of a pharmaceutical formulation comprising:
- (i) an anti-KIR3DL2 antibody that binds to a KIR3DL2 receptor at a concentration of at least 15 mg/ml;
- (ii) polysorbate 80 at a concentration of 0.02-0.2 mg/ml;
- wherein the formulation further comprises:
- (a) one or more buffers;
- and
- (b) a tonicity agent.
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Dependencies are inferred from the claim text.