Back to results
US 2016/0235849 A1Published application
High Concentration Antibody Formulations
AssigneeAmgen Inc.
InventorTimothy D. Osslund
Life of this patent
Estimating the term…
Abstract
Discloses herein are high concentration antibody formulations comprising an anti-sclerostin immunoglobulin and an acetate salt and/or an acetate buffer and methods of use.
Claims14
A sterile liquid formulation that has an absolute viscosity of about 10 cP or less comprising:
- (a) an anti-sclerostin immunoglobulin at a concentration of at least 70 mg/mL;
- and (b) calcium acetate at a concentration ranging from about 1 mM to about 20 mM.
A sterile liquid formulation that has an absolute viscosity of about 10 cP or less comprising:
- (a) an anti-sclerostin immunoglobulin at a concentration of from about 70 mg/mL to about 200 mg/mL;
- and (b) an acetate salt and/or acetate buffer at a concentration ranging from about 10 mM to about 50 mM acetate, wherein the immunoglobulin comprises amino acid sequences of:
- SEQ ID NO:
- 14 and/or SEQ ID NO:
- 12;
- or SEQ ID NO:
- 86 and/or SEQ ID NO:
- 84;
- or SEQ ID NO:
- 68 and/or SEQ ID NO:
- 66;
- or SEQ ID NO:
- 154 and/or SEQ ID NO:
- 152;
- or SEQ ID NO:
- 182 and/or SEQ ID NO:
- 180;
- or SEQ ID NO:
- 208 and/or SEQ ID NO:
- 207;
- or SEQ ID NO:
- 216 and/or SEQ ID NO:
- 214;
- or SEQ ID NO:
- 238 and/or SEQ ID NO:
- 236.
23 more elements
A method for reducing the viscosity of a protein formulation, the method comprising;
- adding calcium acetate at a concentration of between about 1 mM and about 20 mM, to an anti-sclerostin immunoglobulin formulation, wherein the formulation comprises an immunoglobulin at a concentration of from about 70 mg/mL to about 200 mg/mL, wherein the viscosity of the formulation with the calcium acetate is reduced compared to the viscosity of an antibody formulation without the calcium acetate.
A sterile liquid formulation that has an absolute viscosity of about 10 cP or less comprising:
- (a) Ab-5 at a concentration of at least 70 mg/mL to about 200 mg/mL;
- (b) calcium acetate at a concentration ranging from about 1 mM to about 20 mM;
- and (c) a polyol such as sucrose, for example, in an amount ranging from about 4% w/v to about 6% w/v.
A sterile liquid formulation comprising:
- (a) an anti-sclerostin immunoglobulin at a concentration of at least 70 mg/mL to about 200 mg/mL, wherein the immunoglobulin comprises amino acid sequences of:
- SEQ ID NO:
- 14 and/or SEQ ID NO:
- 12;
- or SEQ ID NO:
- 86 and/or SEQ ID NO:
- 84;
- or SEQ ID NO:
- 68 and/or SEQ ID NO:
- 66;
- or SEQ ID NO:
- 154 and/or SEQ ID NO:
- 152;
- or SEQ ID NO:
- 182 and/or SEQ ID NO:
- 180;
- or SEQ ID NO:
- 208 and/or SEQ ID NO:
- 207;
- or SEQ ID NO:
- 216 and/or SEQ ID NO:
- 214;
- or SEQ ID NO:
- 220 and/or SEQ ID NO:
- 218;
- or SEQ ID NO:
- 238 and/or SEQ ID NO:
- 236;
- and
- (b) calcium acetate at a concentration ranging from about 1 mM to about 20 mM, wherein the calcium acetate reduces the absolute viscosity of the formulation by at least 10% compared to the viscosity of an antibody formulation without the calcium acetate.
27 more elements
Dependencies are inferred from the claim text.