The Invention relates to a method for PURIFYING iduronate-2-sulfatase (I2S) recombinant from unprocessed biological materials (e.g., a cell culture Medium containing I2S)Through a process that involves less than 6 Chromatography steps of one or more of anion exchange Chromatography cation Exchange Chromatography Mixed Mode Chromatography and Hydrophobic Interaction Chromatography, and the Purified recombinant i2S contains less than 100 ng \/ mg of host Cell Protein (HCP).Preferably, at least 70% of the Purified recombinant i2S contains the residue C Alpha formilglicina (fgly) at the position corresponding to cys59 Human i2S (SEC ID no: 1). It also relates to compositions comprising i2S Purified recombinant containing less than 150 ng \/ mg HCP.LA INVENCION SE REFIERE A UN METODO PARA PURIFICAR IDURONATO-2-SULFATASA (I2S) RECOMBINANTE A PARTIR DE MATERIALES BIOLOGICOS NO PROCESADOS (POR EJEMPLO, UN MEDIO DE CULTIVO CELULAR QUE CONTIENE I2S), MEDIANTE UN PROCESO QUE INVOLUCRA MENOS DE 6 PASOS DE CROMATOGRAFIA DE UNA O MAS DE CROMATOGRAFIA DE INTERCAMBIO ANIONICO CROMATOGRAFIA DE INTERCAMBIO CATIONICO CROMATOGRAFIA DE MODO MIXTO Y CROMATOGRAFIA DE INTERACCION HIDROFOBICA, Y DONDE LA I2S RECOMBINANTE PURIFICADA CONTIENE MENOS DE 100 ng/mg DE PROTEINA DE CELULA HUESPED (HCP). PREFERENTEMENTE, POR LO MENOS 70% DE LA I2S RECOMBINANTE PURIFICADA CONTIENE EL RESIDUO C-alfa-FORMILGLICINA (FGly) EN LA POSICION CORRESPONDIENTE A Cys59 DE I2S HUMANA (SEC ID NO: 1). TAMBIEN SE REFIERE A COMPOSICIONES QUE COMPRENDEN I2S RECOMBINANTE PURIFICADA CONTENIENDO MENOS DE 150 ng/mg HCP.
