| 摘要 |
The present invention relates to a composition containing purified recombinant iduronate-2-sulfatase (I2S) having an amino sequence which shows more than 70% of homogeny with SEQ ID NO:1. The purified recombinant I2S has a conversion ratio of cysteine residues into Calpha-formylglycine (FGly) which corresponds to Cys59 of SEQ ID NO:1 to 70 % or greater, and contains less than 150 ng/mg of host cell protein (HCP). [Reference numerals] (AA) Defrosting UPB, 2-8°C, depth filtration; (BB) Virus inactivation 1% polysorbate 80, 0.3% TnBP; (CC) Ion exchange chromatography Q Sepharose/Q CAPTO 80cm; (DD) Hydroxide apatite type ii chromatography 60cm; (EE) Ion exchange chromatography SP Sepharose FF 60cm; (FF) Phenyl Sepharose FF chromatography 60cm; (GG) Virus filtration planova; (HH) UF/DF addition into a formulation buffer (2mg/ml) 20Mm potassium hydroxide 137 mM NaCl, pH 6.0; (II) 0.2 microfiltration drug substance |
