SIALYLATED GLYCOPROTEIN COMPOSITION AND USES THEREOF
The present application relates to sialylated glycoprotein compositions and methods of their use in treating various conditions and disorders.
1 - 27 . (canceled)
28 . A composition comprising a recombinant glycoprotein, wherein the recombinant glycoprotein is human β-glucuronidase and has a sialylation content of at least 0.7 mol/mol of the recombinant glycoprotein.
29 . The composition of claim 28 , wherein the recombinant glycoprotein has a high level of mannose-6-phosphate (M6P) moieties.
30 . The composition of claim 28 , wherein the recombinant glycoprotein has a sialylation content of at least 1 mol/mol and a high level of M6P moieties of at least 10 mol % of the total glycan of the recombinant glycoprotein.
31 . The composition of claim 28 , wherein the recombinant glycoprotein has a high level of M6P moieties and a M6P dependent half-maximum concentration of no more than 3 nM of the recombinant glycoprotein into human fibroblast cells.
32 . A preparation of a population of a recombinant glycoprotein, wherein the recombinant protein is human β-glucuronidase and wherein at least 10% percentage of the population of the recombinant glycoprotein is sialylated.
33 . The preparation of claim 32 , wherein the recombinant protein has a sialylation content of at least 0.7 mol/mol of the recombinant protein.
34 . The preparation of claim 32 , wherein the recombinant protein has a high level of M6P moieties.
35 . The preparation of claim 32 , wherein the recombinant protein has a sialylation content of at least 1 mol/mol and a high level of M6P moieties of at least 10 mol % of the total glycan of the recombinant glycoprotein.
36 . The preparation of claim 32 , wherein the recombinant glycoprotein has a high level of M6P moieties and an half-maximum uptake concentration of not more than 3 nM of the recombinant glycoprotein into human fibroblast cells.
37 . A method of making the composition of claim 28 comprising expressing the recombinant glycoprotein in a cell culture with a serum or protein free media.
38 . A method of making the preparation of claim 32 comprising expressing the recombinant glycoprotein in a cell culture with a serum or protein free media.
39 . A method of treating multi-system lysosomal storage disorder comprising administering to an individual in need of such treatment an therapeutically effective amount of the composition of claim 28 .
40 . A method for treating a condition or disorder in a subject, comprising administering to the subject a regimen comprising a recombinant glycoprotein that has a sialylation content of at least 0.7 mol/mol of the recombinant glycoprotein, wherein the administration provides a statistically significant therapeutic effect for the treatment of the condition or disorder.