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Cryopreservation system with controlled dendritic freezing front velocity and cryopreservation method

A cryopreservation and low-temperature technology, which is applied in the field of cryopreservation of biopharmaceutical materials, can solve problems that are not conducive to yield and time-consuming

Inactive Publication Date: 2006-11-08
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

For high-volume production, the practice of breaking a large batch into many small batches is time-consuming and detrimental to improving yield

Method used

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  • Cryopreservation system with controlled dendritic freezing front velocity and cryopreservation method
  • Cryopreservation system with controlled dendritic freezing front velocity and cryopreservation method
  • Cryopreservation system with controlled dendritic freezing front velocity and cryopreservation method

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0081] Example 1: The following example describes scaling using the thickness method. Both length and thickness are constant, 12cm and 40cm respectively. A 40-fold increase in volume can be obtained by freezing 10 cm or 42 cm long containers configured in parallel. Freezing time and freezing rate are kept constant.

[0082] growth factor

1

4

20

40

Volume (L)

5

20

100

200

Container length (cm)

10

42

20

417

The number of the 42cm length container

0.25

1

5

10

[0083] Figure 4 A biopharmaceutical material cryopreservation system 200 according to the present invention is shown that is substantially the same as the biopharmaceutical material cryopreservation system 100 except that the temperature sensor 130 is replaced by an internal temperature channel 230 and an internal temperature sensor 216 .

[0084] Figure 5 A portion of a biopharmaceutic...

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PUM

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Abstract

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.

Description

[0001] This application claims priority to US Patent Application No. 09 / 905,488, filed July 13, 2001, the contents of which are incorporated herein by reference. technical field [0002] The invention relates to a cryopreservation method and equipment for biomedical materials, in particular to a cryopreservation system and method capable of keeping the freezing of biomedical materials in containers controllable, including controllable freezing surface speed of dendrites. Background technique [0003] 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. [0004] When applying cryopreservation, i...

Claims

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Application Information

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IPC IPC(8): F25D3/08F25D17/02A61J1/14A61J3/00C12N5/02F25C1/04F25D3/00F25D3/10F25D9/00F25D11/04G01N1/42
CPCF25B2600/07F25C1/04F25C2600/04G01N1/42
Inventor 理查德·维什涅夫斯基埃里克·K·利
Owner 赛多利斯北美公司
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