Method for inactivating virus in vaccine production

A technology for vaccine production and inactivation, applied in microorganism-based methods, biochemical equipment and methods, inactivation/attenuation, etc., which can solve problems such as loss of natural activity, changes in protein spatial structure, and increased antigen loss.

Active Publication Date: 2015-04-08
SINOVAC BIOTECH
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

The fluctuation of temperature will have an important impact on the activity of the antigen: when the temperature is too high, the spatial structure of the protein changes, loses its natural activity, and the antigen loss increases; Cross-links provide stable energy, which cannot achieve the purpose of stabilizing protein structure well

Method used

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  • Method for inactivating virus in vaccine production
  • Method for inactivating virus in vaccine production
  • Method for inactivating virus in vaccine production

Examples

Experimental program
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Effect test

Embodiment 1

[0024] 1. Obtain hepatitis A virus harvest liquid through cell culture 2BS (human diploid) cells.

[0025] 2. After initial purification and fine purification, the hepatitis A virus harvest liquid is relatively pure hepatitis A virus liquid.

[0026] 3. Inactivated hepatitis A virus liquid:

[0027] 1) Clean and disinfect the room, put the purified hepatitis A virus solution and formaldehyde solution at room temperature (18-26°C) overnight (more than 5 hours) to equilibrate.

[0028] 2) Sterilization and filtration of the hepatitis A virus liquid: connect the hepatitis A virus liquid to the sterilization and filtration system of the hepatitis A virus liquid, stir and mix the filtered hepatitis A virus liquid at a speed of 350-450 rpm after the filtration is completed.

[0029] 3) Inactivation: add the formaldehyde solution with a concentration range of 0.018-0.021g / ml after sterilization and filtration into the virus solution through the inactivation system, so that the final...

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Abstract

The invention relates to a method for inactivating virus in vaccine production, belonging to the field of preparation of biological products. According to the method, the conditional parameters of temperature control, stirring rate, the flow rate of adding formaldehyde solution and the like during the inactivation process of the vaccine production can be improved according to the factors influencing the antigen stability, immunogenicity and antigen recovery rate during the inactivation of vaccine virus liquid are improved to acquire optimal inactivation conditions, the antigen loss during inactivation can be reduced, the antigen structure can be stabilized and the immunogenicity can be improved. According to the method, the quality stability and uniformity of products can be guaranteed, and the production cost can be lowered; the inactivation time can be shortened within 2h from 2.5h, the fatigue of people can be reduced, the production efficiency is improved, the intermediate product during vaccine production is prevented from being stored at room temperature for long time, and the quality of vaccines can be improved indirectly.

Description

technical field [0001] The invention belongs to the field of biological product preparation, in particular to a vaccine inactivation method; more specifically to a method for using formaldehyde to inactivate viruses in vaccine production. Background technique [0002] Formaldehyde is currently the most commonly used virus inactivator. It is usually used to inactivate antigens (viruses, bacterial fluids, etc.) in biological products. Methyl derivatives, as the action time prolongs, hydroxymethyl derivatives can cross-link with amides again, making microorganisms lose their toxicity and reproductive ability, but still maintain good immunity; on the other hand, formaldehyde can also make Nucleic acid inactivation, its role is to denature nucleic acid by combining with bases containing amine groups such as adenine, guanine, and cytosine. At present, most inactivated vaccines at home and abroad are prepared by formaldehyde inactivation: after the purified virus liquid (or virus ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N7/06C12R1/93
Inventor 马敏华张健张颖董兴华张星星李静尹卫东
Owner SINOVAC BIOTECH
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