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Cryopreservation system with controlled dendritic freezing front velocity and method thereof

A technology of cryopreservation and freezing system, applied in the field of cryopreservation of biopharmaceutical materials, can solve problems such as integrity damage, contamination and loss of biopharmaceutical products, etc.

Inactive Publication Date: 2006-12-06
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 and method thereof
  • Cryopreservation system with controlled dendritic freezing front velocity and method thereof

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Embodiment Construction

[0012] The inventors have unexpectedly 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 cryopreservation and cryogenic processing of the biopharmaceutical material is performed in a controlled manner so that the freezing rate of the biopharmaceutical material is maintained within a desired range .

[0013] When processing biopharmaceutical materials such as cells for cryopreservation, intracellular ice crystals can form in the cells if the cells freeze too quickly and the water content is too high. As a result, cells may rupture and / or lose viability. On the other hand, if the cells are frozen too slowly, the cells are exposed to concentrated solutes for too long, potentially causing cell damage. As another example, freezing rate is al...

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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 present invention relates to a cryopreservation method and device for biopharmaceutical materials, in particular to a biopharmaceutical material cryopreservation system and method capable of maintaining a controlled dendritic freezing surface velocity. Background technique [0002] The cryopreservation 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 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, especially the pharmaceutical activity, without significant degradation of the biopharmaceutical product or solutes. [0004] Pres...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): F25D17/02A01N1/02C12N5/02F25C1/04F25D11/04G01N1/42
CPCF25C1/04G01N2001/2255F25C2600/04F25B2600/07G01N1/42
Inventor 理查德·维什涅夫斯基
Owner 赛多利斯北美公司
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