| 摘要 |
Disclosed is a biopharmaceutical material cryopreservation system(100) that includes a flexible sterile container(104) comprising a biocompatible polymeric material, and the flexible sterile container(104) containing biopharmaceuticals materials(110), and a freezing system(122) thermally coupled to the biopharmaceutical materials(110) via the flexible sterile container(104), and the freezing system(122) comprising a temperature sensor(116) that monitors a temperature of the biopharmaceutical materials(110) wherein the freezing system(122) comprises a feedback loop constructed to control a dendritic freezing front(128) velocity, within the biopharmaceutical materials(110), in a range from approximately 5 millimeter s per hour to approximately 250 millimeters per hour based on feedback information from the temperature sensor(116).
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