| 摘要 |
The present invention provides a continuous load manifold system for production of ambient temperature stable biological materials, using a vacuum foam drying technology while keeping the temperature inside the material above -20°C comprising:
(a) two or more drying chambers, containing preservation mixtures of the biological material with one or more protective excipients, attached to a condenser by a connector containing a device that allows controlling the flow of water vapor from the drying chambers into the condenser;
(b) a control system for independently and simultaneously controlling the primary drying of the preservation mixtures in each chamber by vaporization under vacuum that includes boiling of the preservation mixture using a simultaneous and independent application of a vacuum and a heat to preservation mixtures in each drying chamber in such way that at least a portion of each preservation mixture remains in a liquid state during the primary drying until the preservation mixture turns into a dry foam that is mechanically stable under vacuum at ambient temperatures; and
(c) a control system for independently and simultaneously controlling secondary vacuum drying of the dry foam obtained during the primary drying by heating said dry foam to an elevated temperature to further desorb water and volatile solutes from the foamed preservation mixture and to increase the glass transition temperature thereof. |
