Stabilizing diluent for polypeptides and antigens

Abstract

Compositions for stabilizing polypeptides or antigens are described. These compositions are useful for stabilizing polypeptides or antigens stored in aqueous formulations. Such formulations can be used for various analytical or other methods.

We claim:  
     
         1 . An aqueous reagent composition comprising a buffer, a blocking agent, a solubilizing agent, a salt, a chelating agent, a detergent, and a preservative at a final pH of 7.5 to 8.5, wherein said composition does not comprise N-dodecanoyl-N-methylglycine or decanoyl N-methylgluconamide.  
     
     
         2 . The aqueous reagent of  claim 1 , wherein said blocking agent is a serum.  
     
     
         3 . The aqueous reagent of  claim 2 , wherein said blocking agent is fetal calf serum.  
     
     
         4 . The aqueous reagent of  claim 1 , wherein said solubilizing agent is glycerol.  
     
     
         5 . The aqueous reagent of  claim 1 , wherein said salt is sodium chloride.  
     
     
         6 . The aqueous reagent of  claim 1 , wherein said chelating agent is EDTA.  
     
     
         7 . The aqueous reagent of  claim 1 , wherein said detergent is Tween 20.  
     
     
         8 . The aqueous reagent of  claim 1 , wherein said preservative is trimethyltetradecylammonium bromide and gentamycin.  
     
     
         9 . The aqueous reagent of  claim 1 , wherein said buffer is sodium phosphate.  
     
     
         10 . The aqueous reagent of  claim 1 , wherein said buffer is sodium phosphate, said blocking agent is fetal calf serum, said solubilizing agent is glycerol, said salt is sodium chloride, said chelator is EDTA, said detergent is Tween-20 and said preservative is trimethyltetradecylammonium bromide and gentamycin.  
     
     
         11 . The aqueous reagent of  claim 1 , further comprising a tissue culture medium or tissue culture media.  
     
     
         12 . The aqueous reagent of  claim 10 , wherein said tissue culture medium is Eagle's minimum essential media.  
     
     
         13 . The aqueous reagent of  claim 1 , wherein the aqueous reagent comprises between 50 mM and 100 mM sodium phosphate, between 2% and 20% v/v fetal calf serum, between 2.5% and 10% v/v glycerol, between 50 mM and 2 M sodium chloride, between 10 mM and 15 mM EDTA, between 0.05% and 0.1% v/v Tween-20 detergent, 0.01% w/v trimethyltetradecylammonium bromide, and 0.5% w/v gentamycin sulfate at a final pH of 7.5 to 8.5.  
     
     
         14 . A method of stabilizing an antigen or polypeptide in solution, comprising placing the antigen or polypeptide in an aqueous reagent comprising a buffer, a blocking agent, a solubilizing agent, a salt, a chelating agent, a detergent, and a preservative at a final pH of 7.5 to 8.5, wherein said reagent does not comprise N-dodecanoyl-N-methylglycine or decanoyl N-methylgluconamide.  
     
     
         15 . The aqueous reagent of  claim 14 , wherein said blocking agent is a serum.  
     
     
         16 . The aqueous reagent of  claim 15 , wherein said blocking agent is fetal calf serum.  
     
     
         17 . The method of  claim 14 , wherein said antigen or polypeptide is derived from a microorganism.  
     
     
         18 . The method of  claim 17 , wherein said microorganism is a virus.  
     
     
         19 . The method of  claim 17 , wherein said microorganism is a bacteria.  
     
     
         20 . The method of  claim 18 , wherein aid virus is influenza.  
     
     
         21 . The method of  claim 20 , wherein said influenza is influenza B.  
     
     
         22 . The method of  claim 14 , wherein said antigen is a polypeptide.  
     
     
         23 . The method of  claim 24 , wherein said polypeptide is a nucleoprotein.  
     
     
         24 . The method of  claim 14 , wherein said aqueous reagent further comprises a tissue culture media or medium.  
     
     
         25 . The method of  claim 24 , wherein said tissue culture medium is a minimum essential media.  
     
     
         26 . A method of detecting a stabilized antigen or polypeptide in an aqueous solution, comprising: 
 a. placing an antigen or polypeptide in an aqueous reagent comprising a buffer, a blocking agent, a solubilizing agent, a salt, a chelating agent, a detergent, and a preservative at a final pH of 7.5 to 8.5, wherein said reagent does not comprise N-dodecanoyl-N-methylglycine or decanoyl N-methylgluconamide; and    b. detecting said antigen or polypeptide using analytical method.    
     
     
         27 . The aqueous reagent of  claim 26 , wherein said blocking agent is a serum.  
     
     
         28 . The aqueous reagent of  claim 27 , wherein said blocking agent is fetal calf serum.  
     
     
         29 . The method of  claim 26 , wherein the analytical method is an immunoassay.  
     
     
         30 . The method of  claim 29 , wherein the immunoassay is an enzyme immunoassay.  
     
     
         31 . The method of  claim 26 , wherein the immunoassay is an optical immunoassay.  
     
     
         32 . The method of  claim 26 , wherein the analytical method is a nucleic acid hybridization method.  
     
     
         33 . An aqueous reagent composition for stabilizing therein an antigen or a polypeptide comprising: a buffer, a blocking agent, a solubilizing agent, a salt, a chelating agent, a detergent, and a preservative at a final pH of 7.5 to 8.5, wherein aid composition does not comprise N-dodecanoyl-N-methylglycine or decanoyl N-methylglucanomide.  
     
     
         34 . The aqueous reagent of  claim 33 , wherein said blocking agent is a serum.  
     
     
         35 . The aqueous reagent of  claim 34 , wherein said blocking agent is fetal calf serum.  
     
     
         36 . The aqueous reagent of  claim 33  further comprising said antigen or polypeptide.  
     
     
         37 . The aqueous reagent of  claim 36  wherein the antigen or polypeptide is derived from a microorganism.  
     
     
         38 . The aqueous reagent of  claim 37 , wherein said microorganism is a virus.  
     
     
         39 . The aqueous reagent of  claim 37 , wherein said microorganism is a bacteria.  
     
     
         40 . The aqueous reagent of  claim 38 , wherein said virus is influenza.  
     
     
         41 . The aqueous reagent of claim  40 , wherein said influenza is influenza B.  
     
     
         42 . The aqueous reagent of  claim 36 , wherein said antigen is a nucleoprotein.