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US 9,751,951 B2Granted
Methods of treatment by administering an anti-BAFFR antibody therapeutic formulation
AssigneeNovartis AG
InventorsMarta Cosenza, Christoph Stark
Life of this patent
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Abstract
Anti-BAFFR antibodies are formulated as liquid formulation comprising a high concentration of the antibody active ingredient for delivery to a patient without high levels of antibody aggregation. The aqueous pharmaceutical composition may include one or more sugars, a buffering agent, a surfactant, and/or a free amino acid.
Claims5
A method of treating an autoimmune disease in a patient in need thereof comprising the step of administering to said patient an aqueous composition having a pH of 6.0 and comprising:
- a hypofucosylated or non-fucosylated anti-B-cell Activating Factor Receptor (BAFFR) antibody wherein the antibody has a concentration of 150 mg/mL and wherein said anti-BAFFR antibody comprise heavy chain CDR1, CDR2 and CDR3 of SEQ ID NOs:
- 3, 4 and 5 respectively, and light chain CDR1, CDR2 and CDR3 of SEQ ID NOs:
- 6, 7 and 8, and:
- (a) (i) 220 mM sucrose as a stabilizer,
- (ii) 20 mM histidine as a buffering agent,
- (iii) 0.04% polysorbate 20 as a surfactant;
- or
- (b) (i) 220 mM trehalose as a stabilizer,
- (ii) 20 mM histidine as a buffering agent,
- (iii) 0.04% polysorbate 20 as a surfactant;
- or
- (c) (i) 120 mM sucrose as a stabilizer,
- (ii) 20 mM histidine as a buffering agent,
- (iii) 0.04% polysorbate 20 as a surfactant, and
- (iv) 50 mM arginine.
12 more elements
Dependencies are inferred from the claim text.