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US Patent Application 20090246225 - Methods of Producing Influenza Vaccine Compositions

Application 20090246225 Filed on December 8, 2008. Published on October 1, 2009

Inventors

Assignee

US Class

424/209.1Orthomyxoviridae (e.g., influenza virus, fowl plague virus, etc.)

Attorney, Agent or Firm

International Classes

A61K 39/145
A61P 31/16


Claims


1-67. (canceled)

68. A method of making a liquid refrigerator stable live influenza virus vaccine composition comprising:(a) concentrating a live influenza viral harvest by cross flow filtration; and(b) washing the concentrated viral harvest with a buffer by cross flow filtration,wherein the composition comprises, from about 5% to about 10% sucrose, about 1% to about 2% arginine, about 1% to about 4% gelatin, and less than 5% normal allentoic fluid, and 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 method of claim 68, wherein the viral harvest is from eggs.

70. The method of claim 68, wherein the viral harvest is from cell culture.

71. The method of claim 68, wherein the influenza viral harvest is concentrated 10× to 200×.

72. The method of claim 68, wherein the concentrated viral harvest is washed with about 5 volumes of buffer, wherein 1 volume equals the volume of the viral harvest prior to concentration.

73. The method of claim 68, wherein the volume after washing is the same as the volume of the concentrated virus before washing.

74. The method of claim 68, wherein the buffer comprises sucrose, potassium phosphate and glutamate (SPG).

75. The method of claim 68, wherein the viral harvest is stabilized prior to concentrating.

76. The method of claim 75, wherein the viral harvest is stabilized by adding a buffer comprising SPG.

77. The method of claim 68, wherein the viral harvest is clarified prior to concentrating.

78. The method of claim 68, wherein the composition comprises from about 1% to about 2% arginine.

79. The method of claim 68, wherein the influenza virus composition comprises about 1% gelatin.

80. The method of claim 68, wherein the composition comprises from about 7% to about 10% sucrose.

81. The method of claim 68, wherein the composition further comprises from about 5 mM to about 200 mM potassium phosphate buffer.

82. The method of claim 81, wherein the potassium phosphate buffer is at pH 7.2.

83. The method of claim 81, wherein the composition comprises about 100 mM potassium phosphate buffer.

84. The method of claim 81, wherein the composition comprises from about 10 mM to about 12 mM potassium phosphate buffer.

85. The method of claim 68, wherein the composition has a pH of 7.2.

86. The method of claim 68, wherein the composition does not comprise EDTA.

87. The method of claim 68, wherein the influenza virus is cold adapted.

88. The method of claim 68, wherein the potency is measured in fluorescent focus units.

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