Buffer formulations for enhanced antibody stability
AssigneeOutlook Therapeutics, Inc.
InventorsJohn Cini, Athena Nagi, Maria Taddei
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Abstract
The invention provides buffered formulations of adalimumab. The formulations comprise a buffer comprising an acetate salt, mannitol, glacial acetic acid, sodium chloride, and polysorbate 80. The formulations have an acidic pH, and enhance the thermal, conformational and colloidal stability of antibodies, including the adalimumab antibody.
Claims82
A buffered antibody formulation, comprising an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 2, a buffer comprising from about 0.7 mM to about 1.3 mM of an acetate salt, from about 200 mM to about 206 mM of mannitol, from about 16 mM to about 22 mM of glacial acetic acid, and from about 24 mM to about 28 mM of sodium chloride, and about 0.07% (v/v) to about 0.15% (v/v) of polysorbate 80, wherein the antibody formulation has a pH of from about 5.1 to about 5.3.
A buffered antibody formulation, comprising an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 2, a buffer comprising about 0.8 mM to about 1.2 mM of an acetate salt, about 201 mM to about 205 mM of mannitol, about 17 mM to about 21 mM of glacial acetic acid, and about 25 mM to about 27 mM of sodium chloride, and about 0.08% to about 0.15% (by volume) of polysorbate 80, wherein the antibody formulation has a pH of from about 5.1 to about 5.3.
A buffered antibody formulation, comprising an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 2, a buffer comprising about 0.9 mM to about 1.1 mM of an acetate salt, about 202 mM to about 204 mM of mannitol, about 18 mM to about 20 mM of glacial acetic acid, and about 25.35 mM to about 26.35 mM of sodium chloride, and about 0.09% to about 0.11% (by volume) of polysorbate 80, wherein the antibody formulation has a pH of from about 5.1 to about 5.3.
A buffered antibody formulation, comprising an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a light chain comprising the amino acid sequence of SEQ ID NO:
- 2, a buffer comprising about 1 mM of sodium acetate trihydrate, about 203 mM of mannitol, about 19 mM of glacial acetic acid, and about 26.35 mM of sodium chloride, and about 0.1% (by volume) of polysorbate 80, wherein the antibody formulation has a pH of about 5.2.
A buffer formulation for antibody storage, comprising a buffer comprising from about 0.7 mM to about 1.3 mM of an acetate salt, from about 200 mM to about 206 mM of mannitol, from about 16 mM to about 22 mM of glacial acetic acid, and from about 24 mM to about 28 mM of sodium chloride, and about 0.07% (v/v) to about 0.15% (v/v) of polysorbate 80, wherein the formulation has a pH of from about 5.1 to about 5.3.
Dependencies are inferred from the claim text.