Tapered slot cryopreservation system with controlled dendritic freezing front velocity

摘要

A biopharmaceutical material cryopreservation system, including a flexible sterile container comprising a biocompatible polymeric material, and the flexible sterile container containing biopharmaceuticals materials, and a freezing system removably coupled to the flexible sterile container via a tapered slot and the freezing system thermally coupled to the biopharmaceutical materials via the flexible sterile container and the tapered slot; wherein the freezing system comprises a feedback loop constructed to control a dendritc freezing front velocity, within the biopharmaceutical materials, in a range from approximately 5 millimeters per hour to approximately 250 millimeters per hour based on feedback information from the temperature sensor. Also disclosed are methods of cryopreservation of biopharmaceutical materials, and methods of linearly scaling processes for cryopreservation of biopharmaceutical materials.