Patent ID: 6664099
Filing Date: 2003-12-16
Classification: A61K,C12N,Y02A,Y10S

Abstract:
A method of preserving a biologically-active material comprising a live virus or mycoplasma which method comprises the steps:(i) mixing an aqueous suspension of the biologically-active material with a sterile aqueous solution of trehalose to give a trehalose concentration in the mixture in the range of from 2.5 to 8% w/v; (ii) subjecting the mixture to primary drying, for 30 to 60 minutes, at a pressure of less than atmospheric pressure and at a temperature initially no greater than 37Â° C., and which is controlled not to fall to 0Â° C. or below and which finally is no greater than 40Â° C. to form a glassy porous matrix comprising glassy trehalose having a residual moisture content of not greater than 10% and containing, within the matrix, desiccated biologically-active material; and (iii) subjecting the glassy porous matrix of step (ii) to secondary drying for 10 to 30 hours at a pressure not greater than 0.1 mbar and at a temperature which finally is in the range of from 40 to 45Â° C. to form a trehalose matrix having a residual moisture content of not greater than 2% containing, within the matrix, desiccated biologically-active material.