Compositions comprising iduronate-2-sulfatase
AssigneeTakeda Pharmaceutical Company Limited
InventorDave Nichols
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Abstract
The present invention provides, among other things, improved methods for purifying I2S protein produced recombinantly for enzyme replacement therapy. The present invention is, in part, based on the surprising discovery that recombinant I2S protein can be purified from unprocessed biological materials, such as, I2S-containing cell culture medium, using a process involving as few as four chromatography columns.
Claims19
A composition comprising purified recombinant iduronate-2-sulfatase (I2S) having an amino acid sequence at least 90% identical to SEQ ID NO:1,
- wherein the purified recombinant I2S comprises at least 70% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO:1 to Cα-formylglycine (FGly),
- wherein the purified recombinant I2S comprises on average at least 16 sialic acids per molecule;
- and
- wherein the purified recombinant I2S has specific activity of at least 20 U/mg as determined by an in vitro 4-MUF-SO4 to 4-MUF conversion assay.
A composition comprising purified recombinant iduronate-2-sulfatase (I2S) having an amino acid sequence at least 90% identical to SEQ ID NO:1,
- wherein the purified recombinant I2S comprises at least 70% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO:1 to Cα-formylglycine (FGly),
- wherein the purified recombinant I2S comprises on average at least 16 sialic acids per molecule;
- and
- wherein the purified recombinant I2S has specific activity of at least 40 U/mg as determined by an in vitro sulfate release activity assay using heparin disaccharide as substrate.
Dependencies are inferred from the claim text.