Anti A Beta Antibody Formulation
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Abstract
The present invention provides formulations for maintaining the stability of Aβ binding polypeptides, for example, Aβ antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.
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Citations
117 Claims
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1-86. -86. (canceled)
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87. A stable formulation, comprising:
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(a) a humanized 3D6 antibody or antigen binding fragment thereof at a concentration of from about 1 mg/ml to about 100 mg/ml, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO;
1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO;
2;(b) histidine at a concentration of from about 5 mM to about 15 mM; (c) mannitol in an amount of from about 2% w/v to about 6% w/v; (d) methionine at a concentration of from about 5 mM to about 15 mM; and (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v, wherein the formulation has a pH of from about 5.5 to about 6.5. - View Dependent Claims (88, 89, 90, 91, 92, 93, 94, 95)
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96. A stable unit dosage form, comprising:
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(a) a humanized 3D6 antibody or antigen binding fragment thereof in an amount of from about 10 mg to about 250 mg, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO;
1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO;
2;(b) histidine at a concentration of from about 5 mM to about 15 mM; (c) mannitol in an amount of from about 2% w/v to about 6% w/v; (d) methionine at a concentration of from about 5 mM to about 15 mM; and (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v, at a pH of from about 5.5 to about 6.5. - View Dependent Claims (97, 98, 99, 100, 101, 102, 103, 104, 105)
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106. A pharmaceutical product, comprising:
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(i) a glass vial comprising a stable humanized 3D6 antibody formulation, the formulation comprising; (a) a humanized 3D6 antibody or antigen binding fragment thereof in an amount of from about 10 mg to about 250 mg, wherein the humanized antibody or antigen binding fragment comprises a light chain variable region having an amino acid sequence as set forth in residues 1-112 of SEQ ID NO;
1 and a heavy chain variable region having an amino acid sequence as set forth in residues 1-119 of SEQ ID NO;
2;(b) histidine at a concentration of from about 5 mM to about 15 mM; (c) mannitol in an amount of from about 2% w/v to about 6% w/v; (d) methionine at a concentration of from about 5 mM to about 15 mM; and (e) polysorbate in an amount of from about 0.001% w/v to about 0.01% w/v, wherein the formulation has a pH of from about 5.5 to about 6.5; and (ii) labeling for use comprising instructions to use the appropriate volume of the antibody formulation necessary to achieve a dose of from about 0.01 mg to about 5 mg per kg of patient body weight. - View Dependent Claims (107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117)
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Specification