Method for preparing group A meningococcal capsular polysaccharide conjugate vaccine

A technology of meningococcal and capsular polysaccharides, applied in the field of biomedicine, can solve the problem of low yield of polysaccharides, achieve the effect of increasing the yield of binding and overcoming steric hindrance

Inactive Publication Date: 2015-11-18
CHENGDU OLYMVAX BIOPHARM
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Problems solved by technology

[0007] The technical problem to be solved by the present invention is to provide a method for preparing a group A meningococcal capsular polysaccharide conjugate vaccine, so as to overcome the problem of low yield of the conjugated polysaccharide of the existing group A meningococcal capsular polysaccharide conjugate vaccine

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  • Method for preparing group A meningococcal capsular polysaccharide conjugate vaccine
  • Method for preparing group A meningococcal capsular polysaccharide conjugate vaccine

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Embodiment

[0022] A preparation method of group A meningococcal capsular polysaccharide conjugate vaccine, comprising the following steps:

[0023] B1: Dilute group A meningococcal capsular polysaccharide with water for injection to a solution of 8 mg / ml, keep the temperature at 20°C, and adjust the pH to 10.50;

[0024] B2: adding cyanogen bromide equal to the mass of the polysaccharide described in B1 for activation treatment, maintaining pH 10.5 for activation for 20 minutes, and adjusting the pH to 8.5;

[0025] B3: adding sebacic acid dihydrazide solution of equal volume and concentration to the polysaccharide solution described in B1 for coupling reaction, maintaining pH 8.5 for 15 minutes;

[0026] B4: Dilute the reactant obtained in B3 multiple times - concentrate by ultrafiltration, remove residual cyanogen bromide, and obtain group A meningococcal polysaccharide-sebacic acid dihydrazide derivative;

[0027] B5: Add a tetanus toxoid protein solution equal in quality to the poly...

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Abstract

The invention relates to a method for preparing group A meningococcal capsular polysaccharide conjugate vaccine. The method includes the following steps that group A meningococcal capsular polysaccharide is diluted, activated and coupled into a group A meningococcal polysaccharide-sebacic dihydrazide derivative together with sebacic dihydrazide; then the group A meningococcal polysaccharide-sebacic dihydrazide derivative and a tetanus toxoid solution are subjected to a catalytic reaction through carbodiimide, so that group A meningococcal capsular polysaccharide and carrier protein conjugate is obtained. According to the method, the sebacic dihydrazide is used as a coupling agent in the preparation process of the group A meningococcal conjugate vaccine; compared with adipic dihydrazide, the sebacic dihydrazide has two more methylenes on carbon chains, molecular chains are longer, the steric hindrance of biomacromolecules can be better resisted, and the conjugation yield is increased.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for preparing a group A meningococcal capsular polysaccharide-conjugated vaccine. Background technique [0002] Neisseria meningitidis (Nm) is the primary pathogenic bacteria of meningitis and fulminant sepsis, and the incidence of epidemic meningitis (hereinafter referred to as meningitis) is often sporadic, and there is no obvious difference among cases. Associated outbreaks, usually in small-scale fashion, can turn into catastrophic and unpredictable endemic epidemics in some areas. There are about 500,000 meningitis cases and 50,000 deaths worldwide each year. Nm is an aerobic, Gram-negative, capsuled, usually in pairs (diplococcus). Nm can be divided into 13 serogroups according to the chemical composition of capsular polysaccharides, and can be divided into different serotypes and serotypes according to the antigenic difference of outer membrane protein (Outermem-brane...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/385A61K39/095A61P31/04
CPCA61K39/095A61K39/385
Inventor 伍长华王乾李洪光
Owner CHENGDU OLYMVAX BIOPHARM
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