| 摘要 |
The present invention relates to a composition containing purified recombinant iduronate-2-sulfatase having an amino sequence which shows more than 70% of homogeny with SEQ ID NO: 1. The purified recombinant iduronate-2-sulfatase has a transformation ratio of cysteine residues to Cα-formylglycin (FGly) which corresponds to Cys59 of more than 70% of SEQ ID NO: 1, 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) Add UF/DF inside a formulation buffer (2mg/ml) 20mM, Potassium hydroxide 137 mM NaCl, pH6.0; (II) 0.2 microfiltration drug substance |
