FIELD: pharmaceutical industry.
SUBSTANCE: invention relates to the pharmaceutical industry, namely to a method for preserving biological material. A method for the conservation of biological materials, which includes the following stages: ensuring the presence of an aqueous composition to be preserved in a container, while the composition to be preserved includes one or more biological materials; placement of the container and the composition to be preserved in it on a temperature-controlled shelf in the vacuum chamber of the lyophilizer, where the temperature-controlled shelf is adapted to provide some shelf temperature, and the vacuum chamber is adapted to provide underpressure in it; the implementation of the partial freezing protocol, while the partial freezing protocol includes: lowering the shelf temperature below 0°C and maintaining the temperature of the composition to be preserved above Tg', thereby ensuring the transition of the composition to be preserved into a two-phase slush-like state, where the composition to be preserved contains ice crystals and a liquid aqueous phase in a two-phase slush-like state; the implementation of the primary drying protocol, while the specified primary drying protocol includes raising the shelf temperature above 0°C and maintaining the underpressure below 1.0 Torr, thereby ensuring the boiling of water from the composition to be preserved in a two-phase slush-like state with the formation of a mechanically stable vitreous foam; and the implementation of the secondary drying protocol, while the specified secondary drying protocol includes increasing the shelf temperature above 40°C in order to increase to the glass transition temperature of mechanically stable vitreous foam.
EFFECT: method described above makes it possible to improve the method for preservation of biological materials using conventional lyophilizers.
15 cl, 4 dwg, 5 tbl, 8 ex
