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Last Updated: March 29, 2024

Claims for Patent: 9,815,903


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Summary for Patent: 9,815,903
Title:DAC HYP compositions
Abstract: The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.
Inventor(s): Hartman; Taymar E. (Redwood City, CA), Sauer; Paul W. (Fremont, CA), Burky; John E. (Newark, CA), Wesson; Mark C. (San Ramon, CA), Huang; Ping Y. (Fremont, CA), Robinson; Thomas J. (San Mateo, CA), Partridge; Braeden D. (Sunnyvale, CA), Tso; J. Yun (Menlo Park, CA)
Assignee: AbbVie Biotherapeutics Inc. (Redwood City, CA)
Application Number:15/587,127
Patent Claims:1. 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.

2. The pharmaceutical composition of claim 1, comprising about 150 mg/mL daclizumab.

3. The pharmaceutical composition of claim 1, further comprising sodium succinate.

4. The pharmaceutical composition of claim 3, wherein the sodium succinate is present in about 5.9 mg/mL.

5. The pharmaceutical composition of claim 1, further comprising succinic acid.

6. The pharmaceutical composition of claim 5, wherein the succinic acid is present in about 0.4 mg/mL.

7. The pharmaceutical composition of claim 1, further comprising sodium chloride.

8. The pharmaceutical composition of claim 7, wherein the sodium chloride is present in about 5.8 mg/mL.

9. The pharmaceutical composition of claim 1, further comprising polysorbate 80.

10. The pharmaceutical composition of claim 9, wherein the polysorbate 80 is present in about 0.3 mg/mL.

11. The pharmaceutical composition of claim 1, wherein the pH is about pH 6.0.

12. 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.

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