Recombinant α-L-iduronidase, methods for producing and purifying the same and methods for treating diseases caused by deficiencies thereof

A method of purifying human recombinant α-L-iduronidase having a purity of equal to or greater than about 99% purity, comprising the steps of:

• (a) harvesting and filtering fluid obtained from a culture of Chinese hamster ovary cells transformed with nucleic acids encoding said human recombinant α-L-iduronidase;
• (b) adjusting the pH of the fluid to an acidic pH wherein any potential virus is inactivated and said human recombinant α-L-iduronidase is not harmed, followed by filtration through a 0.2 micron to 0.54 micron filter;
• (c) passing the fluid from step (b) through a Cibracon blue dye interaction chromatography column to capture said human recombinant α-L-iduronidase;
• (d) passing the fluid through a copper chelation chromatography column to remove contaminating Chinese hamster ovary proteins;
• (e) passing the fluid through a phenyl hydrophobic interaction chromatography column to reduce residual leached Cibacron blue dye and copper ions canned over from previous columns;
• and
• (f) concentrating and diafiltering the purified human recombinant α-L-iduronidase;
• wherein said purity of equal to or greater than about 99% purity of human recombinant α-L-iduronidase is measured by μg of contaminating Chinese hamster ovary protein per mg of total protein.