Process for concentration of a polypeptide
The present invention comprises a method of concentrating a composition comprising a polypeptide of interest and the use of such concentrated composition for the treatment of diseases in mammals, in particular by subcutaneous injection.
1. A method of treating metachromatic leukodystrophy comprising administering to a subject in need of treatment a composition comprising at least 25 mg/mL recombinant human arylsulfatase A (rhASA), wherein the amount of rhASA present as aggregates constitutes at least few and less than 5 w/w % of the total amount of rhASA in the composition.
2. The method of claim 1 , wherein the rhASA is present at a concentration no greater than 500 mg/mL.
3. The method of claim 1 , wherein the composition is an aqueous solution.
4. The method of claim 1 , wherein the composition further comprises a detergent.
5. The method of claim 1 , wherein the rhASA contains mannose-6-phosphate residues.
6. The method of claim 1 , wherein the rhASA comprises an amino acid sequence selected from the group consisting of
(i) an amino acid sequence as defined by any one of SEQ ID NOs: 18, 19, or 20; and
(ii) an amino acid sequence at least 95% identical to any one of SEQ ID NOs: 18, 19, or 20.
7. The method of claim 1 , wherein the rhASA is produced in mammalian host cells.
8. The method of claim 7 , wherein the mammalian host cells are human cells.
9. The method of claim 7 , wherein the mammalian host cells are Chinese Hamster Ovary (CHO) cells.