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