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US 2017/0247461 A1Published application
Dac hyp compositions
AssigneeAbbVie Biotherapeutics Inc.
InventorsTaymar E. HARTMAN, Paul W. SAUER, John E. BURKY, Mark C. WESSON, Ping Y. HUANG, Thomas J. ROBINSON, Braeden D. PARTRIDGE, J. Yun TSO
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Abstract
The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.
Claims14
-15. (canceled)
A pharmaceutical composition suitable for subcutaneous administration comprising about 135-165 mg/mL daclizumab,
- wherein the daclizumab has one or more of the following:
- (a) an N-terminal isoform with one pyroglutamate residue and one glutamine residue that comprises 3%-17% of the total daclizumab;
- (b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in about 5% to about 20% of the AUC, the other main peak is G0 glycoform present in about 70% to about 99.2% of the AUC, and the minor peak is G1 glycoform present in 1% to 9% of the AUC when determined according to the method described in Section 7.6.14.
-33. (canceled)
The pharmaceutical composition of claim 1, wherein the pH is about pH 6.0.
A pharmaceutical composition suitable for subcutaneous administration comprising about 150 mg/mL daclizumab,
- wherein the daclizumab has one or more of the following:
- (a) an N-terminal isoform with one pyroglutamate residue and one glutamine residue that comprises 3%-17% of the total daclizumab;
- (b) an N-linked oligosaccharide profile comprising two main peaks and a minor peak, wherein one of the two main peaks is G0-GlcNAc glycoform present in about 5% to about 20% of the AUC, the other main peak is G0 glycoform present in about 70% to about 99.2% of the AUC, and the minor peak is G1 glycoform present in 1% to 9% of the AUC when determined according to the method described in Section 7.6.14;
- and
- wherein the pharmaceutical composition further comprises:
- about 5.9 mg/mL sodium succinate,
- about 0.4 mg/mL succinic acid,
- about 5.8 mg/mL sodium chloride, and
- about 0.3 mg/mL polysorbate 80, and
- wherein the pharmaceutical composition has a pH of about pH 6.0.
7 more elements
Dependencies are inferred from the claim text.