COMPOSITION AND FORMULATION COMPRISING RECOMBINANT HUMAN IDURONATE-2-SULFATASE AND PREPARATION METHOD THEREOF

摘要

A composition comprising recombinant iduronate-2-sulfatase (IDS) and a method for producing a purified recombinant IDS are provided. 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 method for preparing a composition comprising an iduronate-2-sulfatase (IDS) having the amino acid sequence of SEQ ID NO: 1, wherein a molar ratio of the IDS of which amino acid at position 59 in the SEQ ID NO: 1 is formylglycine (FGly) is 65% or higher of the total amount of the IDS in the composition, said method comprising:
(a) subjecting a culture of a host cell to an anion exchange chromatography, wherein the host cell is transfected with a gene encoding an IDS of SEQ ID NO: 1 and the culture contains the IDS, comprising eluting the IDS with a first elution buffer of pH 5.5-7.5; (b) subjecting the eluant obtained in (a) to a hydrophobic chromatography, comprising eluting the IDS with a second elution buffer of pH 5.0-7.0; and (c) subjecting the eluant obtained in (b) to a cation exchange chromatography, comprising eluting the IDS with a third elution buffer of pH 4.0-6.0 to obtain the composition.