Process for concentration of a polypeptide

Abstract

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 - 28 . (canceled) 
     
     
         29 . A pharmaceutical composition for treatment of metachromatic leukodystrophy (MLD) comprising recombinant arylsulfatase A (ASA) at a concentration of at least 25 mg/ml, wherein the amount of ASA present as aggregates constitutes at least few and less than 5 w/w % of the total amount of ASA in the composition. 
     
     
         30 . The pharmaceutical composition of  claim 29 , wherein the composition comprises ASA at a concentration between 25-500 mg/ml. 
     
     
         31 . The pharmaceutical composition of  claim 30 , wherein the ASA is at a concentration of at least 30 mg/ml. 
     
     
         32 . The pharmaceutical composition of  claim 29 , wherein the amount of recombinant ASA present as aggregates constitutes less than 1 w/w % of the total amount of ASA in the composition. 
     
     
         33 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA is in an aqueous solution. 
     
     
         34 . The pharmaceutical composition of  claim 29 , wherein the composition further comprises a detergent. 
     
     
         35 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA contains mannose-6-phosphate residues. 
     
     
         36 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA 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 and 20; and   (ii) an amino acid at least 95% identical to any one of SEQ ID NOs: 18, 19 or 20.   
     
     
         37 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA is recombinant human ASA (rhASA). 
     
     
         38 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA is produced in mammalian host cells. 
     
     
         39 . The pharmaceutical composition of  claim 38 , wherein the mammalian host cells are human cells. 
     
     
         40 . The pharmaceutical composition of  claim 38 , wherein the mammalian host cells are CHO cells. 
     
     
         41 . The pharmaceutical composition of  claim 29 , wherein the recombinant ASA is encoded by a nucleic acid sequence comprising a sequence selected from the group consisting of:
 (i) a nucleic acid sequence as defined by any of SEQ ID NOs: 16 and 17; and   (ii) a nucleic acid sequence at least 95% identical to any one of SEQ ID NOs: 16 and 17.