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AssigneeBiomarin Pharmaceutical Inc.
InventorsMinmin Qin, John M. Henstrand, Gary N. Zecherle, Dan J. Wendt, Wai-Pan Chan, Lin Chen, Paul A. Fitzpatrick, Christopher M. Starr
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The present invention provides a highly purified recombinant human precursor N-acetylgalactosamine-4-sulfatase and biologically active mutants, fragments and analogs thereof as well as pharmaceutical formulations comprising highly purified recombinant human precursor N-acetylgalactosamine-4-sulfatase. The invention also provides methods for treating diseases caused all or in part by deficiencies in human N-acetylgalactosamine-4-sulfatase including MPS VI and methods for producing and purifying the recombinant precursor enzyme to a highly purified form.
A composition comprising precursor human N-acetylgalactosamine-4-sulfatase, wherein said precursor N-acetylgalactosamine-4-sulfatase has a purity of at least equal to or greater than 99% based on total protein wherein said purity is measured using the reverse-phase HPLC method, and wherein the composition is free of detectable bands of about 47-48 kDa upon sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) with Coomassie stain.
A composition comprising precursor human N-acetylgalactosamine-4-sulfatase with a purity of at least equal to or greater than 99% wherein the composition is free of detachable bands of about 47-48 kDa upon SDS-PAGE with Coomassie stain, obtained by the method comprising
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