Production of Recombinant IL-18 Binding Protein

Abstract

The invention relates to a process for the production of IL-18 binding protein (IL-18BP), and to a composition comprising IL-18BP characterized by a specific glycosylation pattern.

1 . An IL-18BP composition comprising a pharmaceutically acceptable surfactant, excipient, carrier, diluent or vehicle and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         2 . The IL-18BP composition according to  claim 1 , wherein said composition comprises a pharmaceutically acceptable surfactant and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         3 . The IL-18BP composition according to  claim 1 , wherein said composition comprises a pharmaceutically acceptable excipient and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         4 . The IL-18BP composition according to  claim 1 , wherein said composition comprises a pharmaceutically acceptable carrier and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         5 . The IL-18BP composition according to  claim 1 , wherein said composition comprises a pharmaceutically acceptable diluent and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         6 . The IL-18BP composition according to  claim 1 , wherein said composition comprises a pharmaceutically acceptable vehicle and IL-18BP having a glycoform profile comprising about 0% to about 15% of basic glycoforms, about 15% to about 30% of less acidic glycoforms, about 45% to about 65% of acidic glycoforms, and about 10% to about 25% of highly acidic glycoforms. 
     
     
         7 . An IL-18BP composition comprising a pharmaceutically acceptable surfactant, excipient, carrier, diluent or vehicle and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans. 
     
     
         8 . The IL-18BP composition according to  claim 7 , wherein said composition comprises a pharmaceutically acceptable surfactant and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans. 
     
     
         9 . The IL-18BP composition according to  claim 7 , wherein said composition comprises a pharmaceutically acceptable excipient and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans. 
     
     
         10 . The IL-18BP composition according to  claim 7 , wherein said composition comprises a pharmaceutically acceptable carrier and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans. 
     
     
         11 . The IL-18BP composition according to  claim 7 , wherein said composition comprises a pharmaceutically acceptable diluent and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans. 
     
     
         12 . The IL-18BP composition according to  claim 7 , wherein said composition comprises a pharmaceutically acceptable vehicle and IL-18BP having a sialylation profile comprising about 15% to about 25% of unsialylated N-glycans, about 15% to about 30% of mono-sialylated glycans, about 35% to about 55% of di-sialylated N-glycans, about 5% to about 15% of tri-sialylated N-glycans and about 1% to about 5% of tetra-sialylated N-glycans.