DAC HYP compositions

Patent metadata

Field	Value
Publication number	US-9815903-B2
Application number	US-201715587127-A
Country	US
Kind code	B2
Filing date	May 4, 2017
Priority date	May 27, 2011
Publication date	Nov 14, 2017
Grant date	Nov 14, 2017

Abstract

The present disclosure relates to compositions of daclizumab suitable for subcutaneous administration and methods of manufacturing thereof.

First claim

What is claimed is:

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.

Assignees

• Abbvie Biotherapeutics Inc

Inventors

• Hartman Taymar E
• Sauer Paul W
• Burky John E
• Wesson Mark C
• Huang Ping Y
• Robinson Thomas J
• Partridge Braeden D
• Tso J Yun

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P37/02

  Immunomodulators · CPC title

• A61P37/06

  Immunosuppressants, e.g. drugs for graft rejection · CPC title

• A61P25/28

  for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia · CPC title

• A61P27/02

  Ophthalmic agents · CPC title