abstract |
A method for preparing a stable cold influenza virus composition in the refrigerator, a method comprising: (a) clarifying a viral crop comprising live influenza viruses by filtration, thereby producing a clarified viral crop; (b) subjecting the clarified viral crop to continuous zonal centrifugation, thereby producing an additional clarified viral crop; (c) diluting and sterilizing by sterile filtration said additional clarified viral crop, thereby producing a sterilized viral crop; and (d) combine the sterilized viral crop with a stabilizer to obtain a final sucrose concentration of 6-8% by weight / volume (w / v), 1-2% arginine in w / v, monosodium glutamic acid at 0 , 05-0.1% in p / ve 0.5-2% hydrolyzed gelatin, whereby a stable flu virus composition is produced in the refrigerator, whose composition has a logarithmic power loss of less than 1.0 for a period of 6 months when stored from 4 ° C to 8 ° C. |