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US 9,849,181 B2Granted
High concentration antibody and protein formulations
OwnerJun Xiang, Xinghang Mainventors
Life of this patent
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Abstract
Provided are salt-free antibody and other protein formulations that are substantially isosmotic and of low viscosity. Also provided are methods for the treatment of diseases using the disclosed formulations.
Claims4
A method for the treatment of a disorder in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation comprising:
- a. 10 mM to 30 mM histidine;
- b. 50 ppm to 200 ppm of a non-ionic surfactant;
- c. 88 mM to 292 mM of a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose, and sucrose;
- d. 10 mM to 50 mM arginine;
- e. 0 mM to 50 mM lysine;
- f. 0 mM to 133 mM glycine or alanine;
- g. 0 mM to 10 mM methionine;
- and
- h. 1 mg/ml to 150 mg/ml of a protein or an chimeric, humanized, or human anti-TFPI IgG2 monoclonal antibody comprising a light chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 2;
- wherein said antibody formulation has a pH ranging from pH 4.0 to pH 6.0 and wherein said protein formulation contains substantially no inorganic salt.
9 more elements
A method for the treatment of hemophilia A or hemophilia B in a patient, said method comprising administering to said patient a therapeutically effective amount of an antibody formulation comprising:
- a. 10 mM to 30 mM histidine;
- b. 50 ppm to 200 ppm of a non-ionic surfactant;
- c. 88 mM to 292 mM of a sugar or sugar alcohol selected from mannitol, dextrose, glucose, trehalose, and sucrose;
- d. 10 mM to 50 mM arginine;
- e. 0 mM to 50 mM lysine;
- f. 0 mM to 133 mM glycine or alanine;
- g. 0 mM to 10 mM methionine;
- and
- h. 1 mg/ml to 150 mg/ml of a protein or an chimeric, humanized, or human anti-TFPI IgG2 monoclonal antibody comprising a light chain comprising the amino acid sequence of SEQ ID NO:
- 1 and a heavy chain comprising the amino acid sequence of SEQ ID NO:
- 2;
- wherein said antibody formulation has a pH ranging from pH 4.0 to pH 6.0 and wherein-said protein formulation contains substantially no inorganic salt.
9 more elements
Dependencies are inferred from the claim text.