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Multivalent meningococcus preparation box, vaccine preparation and preparation method thereof

A meningococcal and vaccine technology, applied in antibacterial drugs, pharmaceutical formulations, bacterial antigen components, etc., can solve the problems of difficult multi-component antigen content analysis and quality control, complex vaccine production process, etc., to maintain high activity, The effect of lyophilization process optimization and solvent parameter optimization

Active Publication Date: 2015-10-07
CANSINO BIOLOGICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although these preparations meet the relevant standards for vaccine declaration and have not affected the immunogenicity and stability of the product after clinical verification, the vaccine production process is complicated, and it is not easy to analyze and quality control the multi-component antigen content in the finished product

Method used

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  • Multivalent meningococcus preparation box, vaccine preparation and preparation method thereof
  • Multivalent meningococcus preparation box, vaccine preparation and preparation method thereof
  • Multivalent meningococcus preparation box, vaccine preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation of A, C, W135, Y group meningococcal polysaccharide or polysaccharide protein binding stock solution

[0039] After the working seeds of meningococcus groups A, C, W135, and Y are recovered, they are inoculated with fermentation medium, and after the fermentation, the bacteria are collected by centrifugation. The bacterial pellet is discarded, and the capsular polysaccharide antigen is separated and purified from the supernatant.

[0040] The purification of polysaccharides adopts ultrafiltration concentration, membrane encapsulation washing, gel separation and other steps to remove phenol, chloroform, protease and other reagents that are obviously harmful to the human body used in the traditional process.

[0041] Qualified purified polysaccharides can be diluted according to a certain ratio and then prepared to obtain a stock solution of meningococcal polysaccharides of groups A, C, W135 and Y.

[0042] The polysaccharide protein binding stock solution needs to be...

Embodiment 2

[0046] Preparation of tetravalent meningococcal vaccine (polysaccharide protein conjugate vaccine) preparation

[0047] Take 10μg group A meningococcal polysaccharide-CRM197 conjugate combination stock solution, 10μg group C meningococcal polysaccharide CRM197 conjugate combination stock solution and place it in a vial, add freeze-dried protectant (20mg mannitol and 5mg sucrose), half stopper Then put it into the lyophilizer cavity, pre-freeze for 240-300 minutes at a temperature of -45℃, reduce the temperature to -35℃ and apply a vacuum, maintain a vacuum of 0.2±0.02mBar, and vacuum at a temperature of -35℃ Dry for 840 to 960 minutes, heat up to 35°C, and dry for 300 to 600 minutes to prepare freeze-dried components;

[0048] Take 10μg Y group meningococcal polysaccharide-CRM197 conjugate combined stock solution and 10μg W135 group meningococcal polysaccharide CRM197 conjugate combined stock solution into a vial, add 10mmol phosphate buffer and 0.45% physiological sodium chloride ...

Embodiment 3

[0053] Preparation of tetravalent meningococcal vaccine (polysaccharide vaccine) preparation

[0054] Take 50μg group A meningococcal polysaccharide stock solution and 50μg group C meningococcal polysaccharide stock solution in a vial, add freeze-dried protective agent (20mg mannitol and 5mg sucrose), half stoppered and put it into the lyophilizer cavity. Pre-freeze at -45℃ for 240~300 minutes, reduce the temperature to -35℃ and vacuum, keep the vacuum degree 0.2±0.02mBar, vacuum dry at -35℃ for 840~960 minutes, and heat up to 35℃, Dry for 300-600 minutes to prepare freeze-dried components;

[0055] Take 50μg Y group meningococcal polysaccharide stock solution and 50μg W135 group meningococcal polysaccharide stock solution in a vial, add a diluent consisting of a mixture of 10mmol phosphate buffer and 0.45% physiological sodium chloride solution, and prepare the dilution Liquid component of the agent;

[0056] In clinical use, the freeze-dried component and the liquid component are...

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Abstract

The invention relates to a multivalent meningococcus product which comprises a freeze-dried component and a liquid component. The freeze-dried component and the liquid component each comprise one or two or three kinds of A, C, Y and W135 group meningococcal polysaccharides, and the same meningococcal polysaccharides exist in the freeze-dried component and the liquid component at different times. In the clinic using process, the freeze-dried component and the liquid component are mixed to obtain the multivalent meningococcus preparation. The multivalent meningococcus product can stably keep the polysaccharide antigen activity, easily detect the effective antigen components in the preparation and control the preparation quality conveniently; in addition, the preparation technology is easy, and the multivalent meningococcus product capable of being stably preserved and high in antigen activity can be obtained by optimizing the polysaccharide antigen freeze-drying technology and the dissolution conditions.

Description

Technical field [0001] The invention relates to the technical field of multivalent vaccines, in particular to a combined preparation capable of stably maintaining the antigenic activity of a multivalent meningococcal vaccine and a preparation method. Background technique [0002] Meningococcus (Meningococcus), also known as Neisseria meningitidis, is the pathogen of epidemic cerebrospinal meningitis (meningococcus for short). According to the different antigens of the meningococcal capsular polysaccharide, the meningococci are divided into more than ten serotypes such as A, B, C, D, X, Y, 29E, W135, H, I, and K groups through hemagglutination test . Common epidemic strains are mainly distributed in A group, C group, W135 group and Y group. [0003] Vaccination is the most cost-effective and effective measure to control meningitis. Group A meningococcal polysaccharide vaccines have been widely used in my country since the 1980s. In 2007, Group A and A+C meningococcal polysaccharid...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/095A61K9/19A61K9/08A61P31/04
CPCA61K9/08A61K9/19A61K39/095A61K39/116
Inventor 李军强司伟雪邓捷朱涛邵忠琦宇学锋毛慧华
Owner CANSINO BIOLOGICS INC
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