PURIFICATION OF IDURONATE-2-SULFATASE

摘要

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.

主权项

1. A composition comprising purified recombinant iduronate-2-sulfatase (I2S) having an amino acid sequence at least 70% identical to SEQ ID NO:1,
wherein the purified recombinant I2S comprises at least about 70% conversion of the cysteine residue corresponding to Cys59 of SEQ ID NO:1 to Cα-formylglycine (FGly) and further wherein the purified recombinant I2S contains less than 150 ng/mg Host Cell Protein (HCP).