Composition and formulation comprising recombinant human iduronate-2-sulfatase and preparation method thereof

摘要

Disclosed is a composition comprising recombinant iduronate-2-sulfatase (IDS). The glycosylation pattern and formylglycine content of the IDS composition are different from those of Elaprase and have superior pharmaceutical efficacy and are safer than the conventional agent and thus can be effectively used for the therapy of Hunter syndrome.

主权项

1. A composition comprising, as an active ingredient, an iduronate-2-sulfatase (IDS) having the amino acid sequence of SEQ ID NO: 1, wherein a cysteine residue at position 59 in the IDS amino acid sequence is converted into formylglycine (FGly) at a molar ratio of 65% or higher.