Stable formulations of antibodies to tslp
AssigneeMerck Sharp & Dohme Corp.
InventorsYunsong Li, Valentyn Antochshuk, Anita Dabbara, Angela Mohs, Alexandre Ambrogelly
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Abstract
The present invention relates to stable formulations of antibodies against human TSLP, or antigen binding fragments thereof.
Claims23
A formulation comprising an anti-TSLP antibody, or antigen binding fragment thereof and a histidine buffer.
The formulation of any one of the above claims, wherein the antibody, or antigen binding fragment thereof, comprises:
- (a) 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;
- or
- (b) a light chain variable region comprising the CDR sequences of SEQ ID NOs:
- 3, 4 and 5 and a heavy chain variable region comprising the CDR sequences of SEQ ID NOs:
- 6, 7 and 8.
The formulation of any one of the above claims, wherein the formulation is stable at ° 5 C. for at least 12 months, 18 months, 24 months or 36 months.
The formulation of any one of the above claims, wherein the anti-TSLP antibody comprises SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7 and SEQ ID NO:8.
The formulation of any one of the above claims, wherein the anti-TSLP antibody comprises SEQ ID NO:1 and SEQ ID NO:2.
The formulation of any one of the above claims, wherein said formulation is stable at a temperature of about ° 5 C.-25° C. for at least 36 months.
The formulation of any one of the above claims, wherein said formulation comprises ≧98.5% monomer of anti-TSLP when stored for at least 12 months at a temperature of about ° 5 C.-25° C.
The formulation of any one of the above claims, wherein said formulation comprises ≧95.0% monomer of anti-TSLP when stored for at least 36 months at a temperature of about ° 5 C.-25° C.
The formulation of any of the above claims, wherein the formulation has a viscosity of less than 4 cP at 20° C. when the antibody is present at a concentration of 100 mg/mL.
Dependencies are inferred from the claim text.