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US 6,664,099 B1Granted
Method for the preservation of viruses and mycoplasma
AssigneeAnhydro Limited
InventorEric Edward Worrall
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Abstract
A biologically-active material comprising a live virus or mycoplasma is preserved by a method of desiccation, without lyophilisation, in a matrix of glassy trehalose having a residual moisture content of not greater than 2%. The method comprises two vacuum drying stages. In a cycle time much shorter than a typical freeze drying process a virus or mycoplasma can be preserved to provide a material that can be rehydrated to give a vaccine having potency.
Claims9
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 37° C., and which is controlled not to fall to 0° C. or below and which finally is no greater than 40° 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 45° C. to form a trehalose matrix having a residual moisture content of not greater than 2% containing, within the matrix, desiccated biologically-active material.
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Dependencies are inferred from the claim text.