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.
Claims20
A method of purifying recombinant arylsulfatase A (ASA) protein, the method comprising
- performing one or more steps of viral inactivation;
- purifying recombinant arylsulfatase A (ASA) protein from an impure preparation by conducting one or more chromatography steps comprising a cation-exchange chromatography;
- pooling eluate from the one or more chromatography steps;
- adjusting the pH of the pooled eluate to between 5.8 and 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 without added buffers.
Dependencies are inferred from the claim text.