US2007161085A1PendingUtilityA1

Methods of Producing Influenza Vaccine Compositions

59
Assignee: MEDLMMUNE VACCINES INCPriority: Feb 25, 2003Filed: Jan 30, 2007Published: Jul 12, 2007
Est. expiryFeb 25, 2023(expired)· nominal 20-yr term from priority
Inventors:George TragerGeorge KembleRichard SchwartzHarshvardhan MehtaVu Truong-LeZhongying ChenAlfred A. PanEric I-Fu TsaoChiaoyin WangLuisa YeePalani Balu
A61P 31/12A61P 31/16A61P 37/04C12N 2760/16151A61K 2039/525B01D 61/145A61K 35/76A61K 39/145C12N 2760/16251A61K 47/183B01D 61/147C12N 2760/16134C12N 7/00C12N 2760/16234A61K 47/26A61K 47/42A61K 47/02A61K 2039/5254A61K 39/12
59
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Claims

Abstract

Methods and compositions for the optimization of production of influenza viruses suitable as influenza vaccines are provided.

Claims

exact text as granted — not AI-modified
1 - 67 . (canceled)  
     
     
         68 . A live influenza virus composition, wherein the composition comprises, from about 5% to about 10% sucrose, about 1% to about 5% arginine, and from about 1% to about 4% gelatin, wherein the composition when stored from about 2° C. to about 8° C. exhibits less than or equal to 1.0 log potency loss in 12 months or less than or equal to 0.080 log potency loss per month.  
     
     
         69 . The live influenza virus composition of  claim 68 , wherein the composition comprises from about 1% to about 2% arginine.  
     
     
         70 . The live influenza virus composition of  claim 68 , wherein the influenza virus composition comprises about 1% gelatin.  
     
     
         71 . The live influenza virus composition of  claim 68 , wherein the composition comprises from about 7% to about 10% sucrose.  
     
     
         72 . The live influenza virus composition of  claim 68 , wherein the composition further comprises from about 5 mM to about 200 mM potassium phosphate buffer.  
     
     
         73 . The live influenza virus composition of  claim 72 , wherein the potassium phosphate buffer is at pH 7.2.  
     
     
         74 . The live influenza virus composition of  claim 72 , wherein the composition comprises about 100 mM potassium phosphate buffer.  
     
     
         75 . The influenza virus composition of  claim 72 , wherein the composition comprises from about 10 mM to about 12 mM potassium phosphate buffer.  
     
     
         76 . The live influenza virus composition of  claim 68 , wherein the composition has a pH of 7.2.  
     
     
         77 . The live influenza virus composition of  claim 68 , wherein the composition comprises from about 10% to about 60% normal allantoic fluid (NAF).  
     
     
         78 . The influenza virus composition of  claim 68 , wherein the composition comprises less then about 5% NAF.  
     
     
         79 . The live influenza virus composition of  claim 68 , wherein the composition does not comprise EDTA.  
     
     
         80 . The live influenza virus composition of  claim 68 , wherein the influenza virus is cold adapted.  
     
     
         81 . The live influenza virus composition of  claim 68 , wherein the potency is measured in fluorescent focus units.  
     
     
         82 . The live influenza virus composition of  claim 68 , wherein the composition when stored at about 4° C. exhibits less than or equal to 1.0 log potency loss in 12 months or less than or equal to 0.080 log potency loss per month.

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