Composition comprising iduronate-2-sulfatase (I2S) formulation that includes; recombinant; purification method of recombinant i2S, Pharmaceutical Composition and use for treating Hunter Syndrome.
The present invention provides, among other things, improved methods for purifying I2S protein produced recombinantly for enzyme replacement therapy. The present invention is, in part, based on the surprising discovery that recombinant I2S protein can be purified from unprocessed biological materials, such as, I2S-containing cell culture medium, using a process involving as few as four chromatography columns.<;p>;La solicitud se refiere a una composició;n que comprende la enzima iduronato-2-sulfatasa (I2S) recombinante que tiene la secuencia de aminoá;cidos de la SEQ ID NO: 1, donde la I2S recombinante purificada comprende por lo menos 70% conversió;n del residuo cisteí;na que corresponde a Cys59 a FGly, y donde el I2S recombinante purificado comprende otras especificaciones estructurales y/o funcionales adicionales.<;/p>;