US2016222101A1PendingUtilityA1

Protein formulations and methods of making same

61
Assignee: ABBVIE INCPriority: Nov 30, 2007Filed: Apr 11, 2016Published: Aug 4, 2016
Est. expiryNov 30, 2027(~1.4 yrs left)· nominal 20-yr term from priority
Inventors:Wolfgang FraunhoferAnnika BartlHans-Juergen KrauseMarkus TschoepeKatharina Kaleta
C07K 16/241C07K 2317/94A61K 38/46A61K 9/08A61K 38/4893A61K 2039/505A61K 39/39591A61K 39/3955A61K 38/385A61K 9/19A61K 38/21C07K 2317/21C07K 1/34C07K 2317/76A61K 38/50A61K 39/395A61K 9/0019C07K 16/244
61
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Claims

Abstract

The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductivity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 . A method of preparing an aqueous formulation comprising a protein and water, the method comprising:
 a) providing the protein in a first solution; and   b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five fold volume exchange with the water has been achieved to thereby prepare the aqueous formulation.   
     
     
         2 . The method of  claim 1 , wherein the diafiltration medium consists of water. 
     
     
         3 . The method of  claim 1 , wherein the first solution is subjected to diafiltration with water until at least about a six-fold volume exchange is achieved. 
     
     
         4 . The method of  claim 1 , wherein the aqueous formulation has a final concentration of excipients which is at least about 95% less than the first solution. 
     
     
         5 . The method of  claim 1 , wherein the protein has a M w  greater than about 150 kDa. 
     
     
         6 . The method of  claim 1 , further comprising adding an excipient to the aqueous formulation. 
     
     
         7 . The method of  claim 1 , wherein the aqueous formulation is a pharmaceutical formulation. 
     
     
         8 . The method of  claim 1 , wherein the protein is an antibody, or an antigen-binding fragment thereof. 
     
     
         9 . The method of  claim 8 , wherein the antibody, or antigen-binding fragment thereof, is selected from the group consisting of a chimeric antibody, a human antibody, a humanized antibody, and a domain antibody (dAb). 
     
     
         10 . The method of  claim 8 , wherein the antibody, or antigen-binding fragment thereof, is an anti-TNRα antibody. 
     
     
         11 . The method of  claim 8 , wherein the antibody, or antigen-binding fragment thereof, is adalimumab. 
     
     
         12 . A method of preparing an aqueous formulation of a protein, the method comprising:
 a) providing the protein in a first solution;   b) subjecting the first solution to diafiltration using water as a diafiltration medium until at least a five-fold volume exchange with the water has been achieved to thereby prepare a diafiltered protein solution; and   c) concentrating the diafiltered protein solution to thereby prepare the aqueous formulation of the protein.   
     
     
         13 . The method of  claim 12 , wherein the diafiltration medium consists of water. 
     
     
         14 . The method of  claim 12 , wherein the first solution is subjected to diafiltration with water until at least about a six-fold volume exchange is achieved. 
     
     
         15 . The method of  claim 12 , wherein the aqueous formulation has a final concentration of excipients which is at least about 95% less than the first solution. 
     
     
         16 . The method of  claim 12 , wherein the protein has a M w  greater than about 150 kDa. 
     
     
         17 . The method of  claim 12 , wherein the aqueous formulation is a pharmaceutical formulation. 
     
     
         18 . The method of  claim 12 , further comprising adding an excipient to the aqueous formulation. 
     
     
         19 . The method of  claim 12 , wherein the protein is an antibody, or an antigen-binding fragment thereof. 
     
     
         20 . The method of  claim 19 , wherein the antibody, or antigen-binding fragment thereof, is selected from the group consisting of a chimeric antibody, a human antibody, a humanized antibody, and a domain antibody (dAb). 
     
     
         21 . The method of  claim 19 , wherein the antibody, or antigen-binding fragment thereof, is an anti-TNRα antibody. 
     
     
         22 . The method of  claim 19 , wherein the antibody, or antigen-binding fragment thereof, is adalimumab.

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