Methods of inactivating viral contaminants

Abstract

The present invention relates to a method for preparing an antibody-containing solution free of viral contaminants starting from cultured cells are described. The method include a step of subjecting the antibody containing solution to a mix of solvent and detergent or to high pH.

1 - 24 . (canceled) 
     
     
         25 . A method for the removal of impurities from a clarified harvest material obtained by (a) culturing host cells which express a protein of interest, (b) harvesting the material in the cell culture and subjecting it to a clarification step, wherein said method comprises (c) treating the resulting clarified harvest with high pH (d) subjecting the high pH treated material to a filtration step to obtain a clarified harvest material substantially free of impurities. 
     
     
         26 . The method of  claim 25 , wherein said impurities comprise host cell proteins, nucleic acids and cell debris. 
     
     
         27 . The method of  claim 25 , wherein said high pH is between about 9 and about 12.5. 
     
     
         28 . The method of  claim 25 , wherein said high pH is at least 10.5 
     
     
         29 . The method of  claim 25 , wherein said high pH is about 11. 
     
     
         30 . The method of  claim 25 , wherein said high pH is obtained using a buffer selected from the group consisting of: Tris, Histidine L-Arginine, phosphate and NaOH. 
     
     
         31 . The method of  claim 25 , wherein said clarified harvest material is first subjected to protein A chromatography, and wherein a resulting protein A eluate is incubated at said high pH. 
     
     
         32 . The method of  claim 25 , wherein said clarified harvest material is first subjected to protein A chromatography, and wherein a resulting protein A eluate is first incubated at said high pH and then neutralized. 
     
     
         33 . The method of  claim 25 , wherein said clarified harvest material is first subjected to protein A chromatography, and wherein a resulting protein A eluate is incubated with NaOH 0.5M to target pH 11 and held for at least 60 min at room temperature. 
     
     
         34 . The method of  claim 25 , wherein said clarified harvest material is first subjected to protein A chromatography, and wherein a resulting protein A eluate is first incubated with NaOH 0.5M to target pH 11 and held for at least 60 min at room temperature, and then neutralized.