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Cryopreservation system with controlled dendritic freezing front velocity

A technology of cryopreservation and freezing system, which is applied in the field of cryopreservation of biopharmaceutical materials, and can solve the problems of destroying sterility, container damage, loss, etc.

Inactive Publication Date: 2004-10-27
赛多利斯北美公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cryoconcentration coupled with low temperature action may lead to a decrease in the solvency of the biopharmaceutical material, causing precipitation
[0007] Finally, it was also found that using traditional techniques could lead to container damage
Rupture or compromise of container integrity is undesirable as this could compromise sterility or result in contamination or loss of the biopharmaceutical product

Method used

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  • Cryopreservation system with controlled dendritic freezing front velocity
  • Cryopreservation system with controlled dendritic freezing front velocity

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Embodiment Construction

[0013] The present inventors have surprisingly found that controlling the freezing rate in cryopreservation and cryogenic processing of biopharmaceutical materials can solve the aforementioned problems. According to one aspect of the present invention, the aforementioned problems can be partially or completely eliminated by ensuring that the cryopreservation and cryoprocessing of the biopharmaceutical material is carried out in a controlled manner such that the freezing rate of the biopharmaceutical material remains within a desired range .

[0014] When handling biopharmaceutical materials such as cells for cryopreservation, intracellular ice crystals can develop in the cells if they are frozen too quickly and with too high a water content. As a result, cells may rupture and / or lose their vitality. On the other hand, if cells are frozen too slowly, the cells are exposed to concentrated solutes for an extended period of time, which can lead to cellular damage. As another exa...

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Abstract

A biopharmaceutical material cryopreservation system is provided that includes a flexible sterile container comprising a biocompatible polymeric material. The flexible sterile container contains biopharmaceuticals materials for freezing and cryopreservation. A freezing system is thermally coupled to the biopharmaceutical materials via the flexible sterile container. The freezing system comprises a temperature sensor that monitors a temperature of the biopharmaceutical materials. Also, the freezing system comprises a feedback loop constructed to control a dendritic 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.

Description

technical field [0001] The invention relates to a cryopreservation method and equipment for biopharmaceutical materials, in particular to a cryopreservation system and method for biopharmaceutical materials capable of maintaining controlled dendrite freezing surface velocity. Background technique [0002] Low temperature preservation of biopharmaceuticals is very important in the manufacture, use, storage and sale of biopharmaceutical products. For example, biopharmaceutical materials are often cryopreserved by freezing between their processing and during storage. Similarly, in some cases, biopharmaceutical materials are frozen and thawed as part of the development process to improve their quality or to simplify the development process. [0003] When cryopreservation is applied, it is desirable to maintain the overall quality of the pharmaceutical product, particularly the activity of the drug, without significant degradation of the biopharmaceutical product or solute. [...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): F25D17/02C12N5/02F25C1/04F25D11/04G01N1/42
CPCF25C2600/04F25B2600/07G01N2001/2255G01N1/42F25C1/04
Inventor 理查德·维什涅夫斯基
Owner 赛多利斯北美公司
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