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Method for viral inactivation by dry heating based on glass transition temperature

A glass transition and virus inactivation technology, applied in heating, disinfection, blood diseases, etc.

Active Publication Date: 2009-01-28
分馏及生物技术法国实验室股份公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0032] Therefore, the problem is to identify measurable multifactorial physicochemical parameters that can provide thresholds for distinguishing satisfactory from unsatisfactory virus inactivation

Method used

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  • Method for viral inactivation by dry heating based on glass transition temperature
  • Method for viral inactivation by dry heating based on glass transition temperature
  • Method for viral inactivation by dry heating based on glass transition temperature

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Embodiment 1: dry heat inactivation of phage PR772 in freeze-dried powder:

[0076] The physical properties of the lyophilized powder are varied in order to adjust the glass transition temperature (Tg).

[0077] The glass transition temperature was determined using a differential scanning calorimeter. The temperature of the differential scanning calorimeter was calibrated using indium (Tm 156.6°C) and n-octadecane (Tm 28.2°C). The samples were subjected to temperatures from -50°C to 130°C at a rate of change of 20°C / min. Experiments were performed at temperatures below room temperature using liquid nitrogen. The glass transition temperature was taken as the midpoint of the endothermic change in the apparent specific heat. The measurement was performed twice, and the average thereof was taken as Tg.

[0078] Heating is performed at a temperature below Tg (ie, in the solid, glassy state), or at a temperature about 20° C. above Tg (ie, in the viscoelastic [rubber] st...

Embodiment 2

[0118] Embodiment 2: dry heating inactivation of PPV in freeze-dried powder

[0119] PPV reduction factors were measured upon heating at 80°C for 12, 24 and 72 hours in lyophilized powders with Tg = 80°C or 90°C.

[0120] The result is as Figure 4 shown in the chart.

[0121] It can be seen that for heating at T=80°C

[0122] - When Tg=T, the reduction factor is close to 4log 10

[0123] - When T10 .

Embodiment 3

[0124] Embodiment 3: PPV, HAV, BVDV, PR772 and Phi174 in the lyophilized powder when T=Tg dry heat inactivation

[0125] PPV, PPV, Reduction factors for HAV, BVDV, PR772 and phage Phil74.

[0126] The result is as Figure 5 and 6 shown in the chart.

[0127] It can be seen that for the less resistant viruses, namely HAV, BVDV and Phi174, heating to T = Tg is sufficient to achieve a reduction factor of 4 log from 24 hours onwards 10 .

[0128] In contrast, for the more resistant viruses, namely PPV and PR772, the heating time had to be extended to 72 hours to achieve a reduction factor close to 4 log 10 .

[0129] As a result, for these highly resistant viruses, since the target is their inactivation, the virus reduction factor and virus inactivation factor can be increased by increasing the difference between T and Tg by increasing the heating temperature T or by decreasing the Tg of the product. live rate.

[0130] In addition, a T-Tg range of 20°C or greater woul...

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Abstract

The invention concerns a method of viral inactivation by dry heating of a virus present or potentially present in a biological product that has been dried according to the glass transition temperature. In a first step, the glass transition temperature of the dried product is determined. In a second step, the product is heated to a temperature not less than the determined glass transition temperature.

Description

[0001] The present invention relates to a virus inactivation method by dry heating. technical field [0002] The risk of viral contamination exists in any solid biological material, its subsequent or derivative products or processed products using such material must be treated with virus inactivation methods for therapeutic or prophylactic purposes. [0003] In the field of therapy and prophylaxis, the active substances used are derived from biological sources or may be contaminated with biological sources during their production processes. [0004] These active substances may be proteins, peptides, polypeptides, antibodies; proteins, peptides, polypeptides, antibodies that may be substituted by lipid or carbohydrate groups; nucleic acids, DNA, RNA, polysaccharides, bacteria, virus particles or others. [0005] The biological source from which they originate or which may contaminate them during the process of their production may be any human or animal tissue, blood, plasma, b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/00
CPCA61L2/0023A61P7/04A61L2/04A61L2/00
Inventor 安妮·巴达特
Owner 分馏及生物技术法国实验室股份公司
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