METHOD OF MICROWAVE VACUUM DRYING SPHERICAL-SHAPED PELLETS OF BIOLOGICAL MATERIALS

摘要

Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.

主权项

1. A method of preparing a dried pellet of a biological material, comprising:
a) dispensing an aliquot of a liquid composition comprising the biological material as a single droplet onto a solid surface, wherein the temperature of the surface is at −90° C. or below, in a manner that maintains the droplet as a single droplet as it contacts and freezes on the surface as a frozen pellet; b) applying microwave radiation to the frozen pellet under a pressure below atmospheric pressure to produce a dried pellet.