Methods for purification of arylsulfatase A
AssigneeTakeda Pharmaceutical Company Limited
InventorsDave Nichols, Igor Quinones-Garcia, Bee Lin Cheang, Mei Huei Jang
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Abstract
The present invention provides, among other things, improved methods for purifying arylsulfatase A (ASA) protein produced recombinantly for enzyme replacement therapy. The present invention is, in part, based on the surprising discovery that recombinant ASA protein can be purified from unprocessed biological materials, such as, ASA-containing cell culture medium, using a process involving as few as four chromatography columns and only one step of post-chromatographic ultrafiltration/diafiltration.
Claims16
A method of purifying recombinant arylsulfatase A (ASA) protein, the method comprising
- purifying recombinant arylsulfatase A (ASA) protein from an impure preparation by conducting two or more chromatography steps;
- pooling eluate from the final chromatography steps;
- adjusting the pH of the pooled elute to between 5.8 to 6.4;
- and
- subjecting the pH-adjusted eluate to a single step of post chromatographic ultrafiltration and/or diafiltration,
- thereby exchanging the purified recombinant ASA protein directly into a saline-based formulation, and
- wherein the method does not comprise more than one ultrafiltration and/or diafiltration step.
Dependencies are inferred from the claim text.