After treatment method for attenuated strain polio inactivated vaccine

A technology for polio and inactivated vaccines, which is applied in the field of post-processing of attenuated strains of polio inactivated vaccines, can solve problems such as inability to meet large-scale production and inability to process virus fluids, and achieve safety and immunogenicity Good, stable and reliable quality, good repeatability

Active Publication Date: 2007-01-31
INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, conventional methods can neither meet the needs of large-scale production nor handle large-scale production of virus fluids. Therefore, it is necessary to improve the existing technology

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1. Clarification: 350 liters of virus fluid cultured in a 550-liter fermenter was filtered and clarified through a three-stage filter column with a pore size of 0.75 μm, 0.45 μm, and 0.22 μm to remove cell debris and impurities in the virus fluid and maintain the purity of the virus fluid. sterile state;

[0022] 2. Concentration: Concentrate the clarified virus liquid to 1.4 liters with a 100,000 molecular weight cut-off ultrafiltration membrane in Millipore cross-flow ultrafiltration equipment;

[0023] 3. Purification:

[0024] A, gel filtration: in the Phamacia Index70 chromatographic column, install Sepharose CL-6B chromatographic filler, flush with 80mmol / L phosphate buffer (pH7.0), get the virus concentrate, add in the chromatographic column, Elute with 80mmol / L phosphate buffer (pH7.0), measure the absorbance at an ultraviolet absorption wavelength of 280, and collect about 600 ml of the first peak (virus peak);

[0025] B. Ion exchange: In the Phamacia Index1...

Embodiment 2

[0029] 1. Clarification: Filter and clarify 350 liters of virus fluid cultured in a 550-liter fermenter through a three-stage filter column with a pore size of 1.0 μm, 0.6 μm, and 0.45 μm to remove cell debris and impurities in the virus fluid and maintain the purity of the virus fluid. sterile state;

[0030] 2. Concentration: Concentrate the clarified virus liquid to 1.4 liters with a 100,000 molecular weight cut-off ultrafiltration membrane in Millipore cross-flow ultrafiltration equipment;

[0031] 3. Purification:

[0032] A, gel filtration: in the Phamacia Index70 chromatographic column, install Sepharose CL-6B chromatographic filler, flush with 80mmol / L phosphate buffer (pH7.2), get the virus concentrated solution, add in the chromatographic column, Elute with 80mmol / L phosphate buffer (pH7.2), measure the absorbance at an ultraviolet absorption wavelength of 280, and collect about 600 ml of the first peak (virus peak);

[0033] B. Ion exchange: In the Phamacia Index1...

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PUM

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Abstract

The present invention is after-treatment process of deactivated vaccine of attenuated polio strain. The large scale cultured virus liquid is three stage filtered in filtering columns of 06-1.0 micron, 0.45-0.6 micron and 0.22-0.45 micron pore size separately, clarified, ultrafiltered and concentrated, chromatographic column purified and deactivated to obtain semi-finished vaccine product with high purity, good immunogenicity, high safety and stable quality for the requirement of producing the attenuated polio strain. The semi-finished vaccine product can meet the requirement of product and may be used to produce Aabin IPV vaccine with stable quality, high safety and excellent immunogenicity.

Description

technical field [0001] The invention relates to a post-processing method of an attenuated strain of inactivated polio vaccine, belonging to medical biology [0002] technology field. Background technique [0003] Poliomyelitis is an acute infectious disease caused by poliovirus types I, II, and III, which is widely spread and extremely harmful. The clinical symptoms cause flaccid paralysis of muscles, especially limbs, which mostly occurs in children, so it is also called "poliomyelitis". Before the advent of the vaccine, the disease was prevalent all over the world. At that time, the incidence rate in my country was 3.18 / 100,000. In the middle and late 1950s, two scientists in the United States, Dr. Salk and Dr. Sabin, successively successfully developed inactivated polio vaccine (IPV) and oral polio vaccine (OPV), thereby preventing and eradicating spinal cord for human beings. Polio provides a powerful weapon. Practice has proved that both vaccines are safe and effect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K39/13A61P31/14C12N7/04
CPCY02A50/30
Inventor 褚嘉祐姜述德孙明波廖国阳张丽旌李卫东俞泳霆李平忠
Owner INST OF MEDICAL BIOLOGY CHINESE ACAD OF MEDICAL SCI
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