Multivalent meningococcal preparation kit, 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 complicated vaccine production process, difficult multi-component antigen content analysis and quality control, and achieve freeze-drying process optimization , maintain high activity, optimize the effect of solvent parameters

Active Publication Date: 2018-04-27
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 meningococcal preparation kit, vaccine preparation and preparation method thereof
  • Multivalent meningococcal preparation kit, vaccine preparation and preparation method thereof
  • Multivalent meningococcal preparation kit, vaccine preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Preparation of meningococcal polysaccharides or polysaccharide-protein-bound stock solutions of groups A, C, W135, and Y

[0039] After recovery, the working seeds of group A, C, W135, and Y meningococci were inoculated with the fermentation medium, and the bacterial cells were collected by centrifugation after fermentation. Discard the cell pellet, and separate and purify the capsular polysaccharide antigen from the supernatant.

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

[0041] The purified polysaccharides that pass the test are diluted according to a certain ratio and then prepared to obtain the stock solution of meningococcal polysaccharides of groups A, C, W135, and Y.

[0042] Before the polysaccharide-protein binding stock solution is p...

Embodiment 2

[0046] Preparation of Quadrivalent Meningococcal Vaccine (Polysaccharide Protein Conjugate Vaccine) Preparation

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

[0048] Take 10 μg of Y group meningococcal polysaccharide-CRM197 conjugate stock solution and 10 μg W135 meningococcal polysaccharide CRM197 conjugate stock solution in a vial, add 10 mmol phosphate buffer and 0.45% physiological sodium chloride solution A diluent composed of a mixture of diluents, prepared as a liqui...

Embodiment 3

[0053] Preparation of Quadrivalent Meningococcal Vaccine (Polysaccharide Vaccine) Preparation

[0054] Take 50 μg of group A meningococcal polysaccharide stock solution and 50 μg of group C meningococcal polysaccharide stock solution into a vial, add a freeze-drying protective agent (20 mg of mannitol and 5 mg of sucrose), put it into the cavity of a freeze dryer after half stoppering, Pre-freeze at -45°C for 240 to 300 minutes, lower the temperature to -35°C to vacuum, maintain a vacuum of 0.2±0.02mBar, vacuum dry at -35°C for 840 to 960 minutes, and heat up to 35°C. Ordinary drying for 300-600 minutes to prepare freeze-dried components;

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

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Abstract

Disclosed is a multivalent meningococcus product, which comprises a freeze-dried component and a liquid component, wherein the freeze-dried component and the liquid component respectively comprise one, two or three of group A, C, Y or W135 meningococcal polysaccharides, and the same meningococcal polysaccharides do not exist in the freeze-dried component and the liquid component at the same times. In clinical usage processes, the freeze-dried component and the liquid component are mixed to obtain the multivalent meningococcus preparation.

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 activity of multivalent meningococcal vaccine antigens and a preparation method. Background technique [0002] Meningococcus (Meningococcus), also known as Neisseria meningitidis, is the pathogenic bacteria of epidemic cerebrospinal meningitis (referred to as meningitis). According to the different antigens of meningococcal capsular polysaccharides, meningococci can be divided into more than ten serotypes such as groups A, B, C, D, X, Y, 29E, W135, H, I, and K through hemagglutination tests . Common epidemic strains are mainly distributed in A group, C group, W135 group and Y group. [0003] Vaccination is the most economical and effective measure to control meningococcal meningitis. my country has widely used group A meningococcal polysaccharide vaccines since the 1980s. In 2007, group A and group A+C mening...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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