Glycopegylated erythropoietin formulations
First Claim
1. A pharmaceutical composition comprising about 0.1 mg/ml to about 1 mg/ml of an erythropoietin peptide and a buffer, the composition having a pH from 5.5 to 6.5, wherein the erythropoietin peptide comprises a glycosyl linking group attached to an amino acid residue or a glycosyl residue of said peptide, wherein the amino acid residue is selected from the group consisting of serine, threonine, and asparagine, said glycosyl linking group comprising a modified sialyl residue having the formula:
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Abstract
The present invention provides conjugates between erythropoietin and PEG moieties. The conjugates are linked via an intact glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. The conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
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30 Claims
- 1. A pharmaceutical composition comprising about 0.1 mg/ml to about 1 mg/ml of an erythropoietin peptide and a buffer, the composition having a pH from 5.5 to 6.5, wherein the erythropoietin peptide comprises a glycosyl linking group attached to an amino acid residue or a glycosyl residue of said peptide, wherein the amino acid residue is selected from the group consisting of serine, threonine, and asparagine, said glycosyl linking group comprising a modified sialyl residue having the formula:
Specification