Lyophilization technique for preparing lyophilized hepatitis A attenuated live vaccine

A technology of live attenuated vaccines and hepatitis A, which is applied in freeze-dried delivery, antiviral agents, and resistance to vector-borne diseases, etc. It can solve the problems of vaccine infectious titer loss, shrinkage, and production cost impact, and achieve elimination The problem of large loss of infectious titer, reduction of loss of infectious titer, and the effect of economical and reasonable production capacity upgrade

Inactive Publication Date: 2008-12-24
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Claims
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AI Technical Summary

Problems solved by technology

Because the existing freeze-drying process is mainly based on the experience accumulated in the process from laboratory development to large-scale production process development, there are the following shortcomings: one, the freeze-drying cycle is long, so that the actual freeze-drying capacity is low and the energy Excess...

Method used

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  • Lyophilization technique for preparing lyophilized hepatitis A attenuated live vaccine
  • Lyophilization technique for preparing lyophilized hepatitis A attenuated live vaccine

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Experimental program
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Effect test

Embodiment 1

[0034] The present invention adopts the following steps to carry out freeze-drying to the semi-finished liquid hepatitis A live attenuated vaccine (commercially available product) of packing, packing capacity 54358 bottles, freeze-drying cycle time 26 hours and 40 minutes:

[0035] (1). Control the shelf temperature of the freeze-drying box of the freeze-dryer to 5°C, and load the half-finished and half-stoppered liquid hepatitis A live attenuated vaccine layer by layer until all the shelves are fully loaded, and then turn off the freeze-drying door, the freeze-drying process starts;

[0036] (2). Control the shelf temperature of the freeze-drying box to 5°C and keep it for 60 minutes;

[0037] (3). Lower the shelf temperature of the freeze-drying box to -40°C at a rate of 1.5°C per minute, and keep the temperature at -40°C for 90 minutes when the shelf temperature reaches -40°C;

[0038] (4). Raise the shelf temperature from -40°C to -24.9°C at a rate of about 0.5°C per minu...

Embodiment 2

[0074] Adopt the following steps to freeze-dry the semi-finished liquid hepatitis A live attenuated vaccine (commercially available product) after subpackaging, packing capacity 55000 bottles, freeze-drying cycle time 21.5~22.5 hours:

[0075] (1). Control the temperature of the freeze-drying box of the freeze-dryer at 10°C, divide the bottles filled with semi-finished and half-stoppered liquid hepatitis A live attenuated vaccine layer by layer until all the shelves are fully loaded, and then turn off the freeze-drying door, the freeze-drying process starts;

[0076] (2). Control the shelf temperature of the freeze-drying box to 10°C and keep it for 30 minutes;

[0077] (3). Lower the shelf temperature of the freeze-drying box to -40°C at a rate of 1.5°C per minute, and keep the shelf temperature at -40°C for 90 minutes;

[0078] (4). The shelf temperature is raised from -40°C to -24.9°C at a rate of 0.60°C per minute, and the heating time is 30 minutes;

[0079] (5). Then l...

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Abstract

The invention provides a freeze-drying technics for preparing freeze-dry hepatitis A attenuated live vaccine. The freeze-dry hepatitis A attenuated live vaccine is made by the technical process of sublimation and dry of the vaccine, removal of the contraction and sublimation at the bottom of the vaccine, invisible sublimation of the vaccine, and resolve and dry of the vaccine. The freeze-drying technics provided by the invention avoids the continuous temperature rise and temperature rise mutation of the vaccine during sublimation period, and reduces and removes the greater loss of vaccine infection titer, thus ensuring the residual moisture content of the vaccine to reach the mark and the vaccine is refined and satiety in shape, the freeze-dry production period of the single batch of the vaccine is reduced by 50 percent, and the energy consumption of the vaccine in a single batch during freeze-dry production period is reduced by 40 percent to 50 percent; in this way, the sustainable development characterized by energy saving, energy reduction, pollution reduction, and effect increment is realized. The freeze-drying technics is suitable for virulence attenuated live vaccine and live extract preparation in laboratory development process, particular for large-scale production of the products.

Description

technical field [0001] The invention relates to a method for preparing a freeze-dried live attenuated hepatitis A vaccine, in particular to a freeze-drying process suitable for large-scale freeze-dried live attenuated hepatitis A vaccine, and belongs to the technical field of biological products. Background technique [0002] In the large-scale production process of live attenuated hepatitis A vaccine, the freeze-drying process is one of the essential key processes for rebuilding the stability of vaccine infectivity titer. Because the existing freeze-drying process is mainly based on the experience accumulated in the process from laboratory development to large-scale production process development, there are the following shortcomings: one, the freeze-drying cycle is long, so that the actual freeze-drying capacity is low and the energy Excessive consumption. The scale of modern vaccine production often requires each freeze dryer to produce millions or even tens of millions ...

Claims

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Application Information

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IPC IPC(8): A61K39/29A61K9/19A61P1/16A61P31/14
CPCY02A50/30
Inventor 申峰杨净思谢忠平陶泓李卫东张丽旌邵聪文张云昆陈洪波邓自君
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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