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Vacuum assisted preservation of biological products, particularly vaccines
专利权人:
Inc.;Merial
发明人:
GENIN, Noel
申请号:
ES12726998
公开号:
ES2626297T3
申请日:
2012.05.31
申请国别(地区):
ES
年份:
2017
代理人:
摘要:
A vitrification process of biological material comprising the steps of formulating a liquid biological preparation, subjecting the preparation to controlled changes in pressure and temperature to reduce the moisture content of the formulation to less than about 5% by weight, thus vitrifying the biological material; in which the process further comprises the steps of: (a) adding to the liquid preparation active biological components, stabilizers, which reduce or eliminate the damage induced by subjecting the biological components to cryogenic preservation media, including pearl granulation, vitrification and lyophilization, and optionally add one or more adjuvants; (b) fill vials with the biological preparation of step (a); (c) loading vials in a temperature controlled container, in which the temperature is between -15 ° C and 10 ° C, particularly between -10 ° C and 5 ° C, and even more particularly about 5 ° C; (d) reduce the air pressure of the controlled temperature vessel until a pressure is obtained within the range of 15-30 mbar; (e) maintain the pressure obtained during step (d) for between 5 and 20 minutes, particularly between 10 and 15 minutes, to allow the product temperature to stabilize and to allow volatile gases, including carbonates, to be released. of the biological preparation, in which the temperature of the vessel follows about 4 ° C to about 6 ° C, or about 5 ° C during this stage; (f) decrease the air pressure in the vessel to approximately 4 to approximately 7 mbar, or approximately 5 mbar, for between approximately 5 and approximately 20 minutes; (g) maintain the pressure of step (f) for about 30 to about 60 minutes, which allows the biological preparation to become more concentrated; (h) increase the temperature of the container from negative to positive temperature (between approximately 30 ° C and approximately 50 ° C) over the course of between 45 and 85 minutes, or approximately 60 minutes, and keep the pressure constant until it reaches
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