Patent ID: 8459046

Claim:
A process for the preparation of a batch of cryogranules of an aqueous extract of a naturally occurring pollen allergen or naturally occurring mite allergen directly in a container used for storage, said process comprising the steps of: (a) providing an aqueous solution comprising said extract, of said naturally occurring pollen allergen or said naturally occurring mite allergen in a concentration in the range of 5-100 mg/mL, said aqueous solution having a freezing temperature; (b) providing a container comprising therein liquid nitrogen as a cryogenic medium; (c) dividing the aqueous solution into droplets by pumping the aqueous solution by means of a dispensing pump to a filling head comprising a plurality of apertures using a flow rate of 0.060 to 25 mL/min per aperture so as to form 1-4 drops per second, the filling head and apertures from which the droplets are formed being arranged just above the opening of the container, within the opening path, or within the container comprising the cryogenic medium, and adding said droplets directly to the container containing the cryogenic medium, whereby said droplets freeze to form cryogranules of the liquid composition having an average diameter in the range of 0.5-10 mm; and (d) sealing the container containing the cryogranules of the liquid composition with sealing means, and storing the container containing the cryogranules of the liquid composition at a temperature in the range of −40° C. to −10° C., wherein the batch of cryogranules are stored without being freeze-dried and able to be stored for more than one year at a temperature in the range of −40° C. to −10° C. without loss of the allergen activity.