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Production process of 23-valent pneumococcal polysaccharide vaccine

A pneumococcal polysaccharide and pneumococcal technology, applied in the direction of bacteria, microorganisms, antibacterial drugs, etc., can solve the problems of increasing operational safety hazards, affecting product safety, polluting the production environment, etc., to prevent environmental and personnel hazards, Good safety and immunogenicity, good polysaccharide stability

Pending Publication Date: 2022-03-01
BEIJING ZHIFEI LVZHU BIOPHARM +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The phenol introduced in the process is highly toxic, pollutes the production environment, and affects the safety of the product. The use of a large amount of organic ethanol also increases the operational safety hazard

Method used

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  • Production process of 23-valent pneumococcal polysaccharide vaccine
  • Production process of 23-valent pneumococcal polysaccharide vaccine
  • Production process of 23-valent pneumococcal polysaccharide vaccine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Example 1: Comparison of fermentation cell concentration and polysaccharide yield under different glucose feed amounts (taking type 8 as an example)

[0070] (1) Use Columbia blood agar plate medium to open type 8 working strains, place at 37±1°C, 10% CO 2 Under the following conditions, a bacterial lawn can basically be formed within 24 hours. The revived strains are stored in liquid medium (about 1L) at 37±1°C, 4%~6%CO 2 Under the conditions of expansion and cultivation, a turbid bacterial liquid gradually formed within 12 hours. Inoculate the cultured bacterial liquid into 9L culture medium and scale up the culture. In 100L fermenter (90L culture medium), 1000L fermenter (400L culture medium) step by step scale-up culture. During the fermentation period, the culture conditions are controlled as follows: temperature 36-38°C, pH value 6.8-7.2, stirring speed 40-100 rpm, ventilation rate 0.1-0.4V / V / M, and fermentation time no more than 10 hours.

[0071] (2) During ...

Embodiment 2

[0074] Example 2: Effects of different lysing agent concentrations on bactericidal effect and polysaccharide antigenicity (taking types 3, 7F, and 18C as examples)

[0075] We chose DOC concentrations of 0.03%, 0.06%, 0.12% and 0.24%, observed the killing of Streptococcus pneumoniae by different concentrations of DOC at different reaction times, and carried out single diffusion experiments on agar plates prepared with corresponding antiserum , by observing the diameter of the diffusion ring to judge the change of polysaccharide antigenicity, the results are shown in the table below. It can be seen from the table: when the lysing agent concentration reaches 0.06% inactivation for 3 hours, the bacteria can be completely inactivated, and the bacteria liquid after the inactivation of the DOC concentration of 0.06%, 0.12% and 0.24%, the diameter of the diffusion ring of the single diffusion experiment is equivalent, It indicated that different concentrations of lysing agents had no...

Embodiment 3

[0079] Example 3: Comparison of the quality of pneumonia polysaccharides obtained by different lysis pH values ​​(taking type 5 as an example)

[0080] Add sodium deoxycholate solution to the harvested type 5 pneumococcal polysaccharide culture solution to sterilize, the final concentration of sodium deoxycholate is 0.12%, and inactivate for more than 4 hours.

[0081] Take 30L of each of the above feed liquids, adjust the pH value to 3.5, 4.0, 4.5, 5.0, and 5.5 with acetic acid solution, and let it settle for 30 minutes; collect the supernatant by centrifugation, adjust the pH value to 6.9±0.2, and use it after clarification and filtration Less than 20 times the volume of 0.001mol / L phosphate buffer was concentrated by ultrafiltration to about 800-1000ml, and samples were taken to determine the polysaccharide content and protein content of the feed liquid. The results are shown in Table 3. As the pH of the lysing agent decreased, the proportion of proteoglycan in the feed liq...

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Abstract

The invention discloses a production process of a 23-valent pneumococcus polysaccharide vaccine, which comprises the following steps: CTAB (cetyltrimethyl ammonium bromide) precipitation, sodium chloride dissociation, CTAB (cetyltrimethyl ammonium bromide) precipitation, ultrafiltration, hydroxyapatite chromatography, ultrafiltration and freeze-drying for polysaccharide purification, so that the use of dangerous organic ethanol and high-toxicity phenol is avoided. Particularly, most of CTAB (cetyltrimethyl ammonium bromide) and impurities introduced into the polysaccharide solution are removed by sodium iodide, and residual impurities are removed by combining tangential flow ultrafiltration membrane bag ultrafiltration and chromatographic column chromatography, so that the prepared polysaccharide is higher in purity and safer, and in addition, the method for obtaining the polysaccharide by freeze drying can better maintain the performance of the polysaccharide and the polysaccharide obtaining stability. The production process is simple to operate, safe and efficient, and the obtained 23-valent pneumococcal polysaccharide vaccine is excellent in immunogenicity.

Description

technical field [0001] The invention belongs to the field of pneumonia vaccines and relates to a 23-valent pneumococcal polysaccharide vaccine (including 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 23 serotypes of Streptococcus pneumoniae including 18C, 19A, 19F, 20, 22F, 23F and 33F). Background technique [0002] Streptococcus pneumoniae is a Gram-positive pathogenic bacteria that was first isolated and identified in 1881. The chemical composition of the mucus layer on the surface of pneumococcus is polysaccharide capsule, which is one of the main pathogenic substances and has antigenicity. Due to its different structures, pneumococcus is divided into more than 90 serotypes. The capsular polysaccharide of Streptococcus pneumoniae is immunogenic and can stimulate the production of protective antibodies. 4-valent, 14-valent, and 23-valent pneumonia polysaccharide vaccines have emerged one after another. Among them, the 23-valent pneumococcal polysacchari...

Claims

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Application Information

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IPC IPC(8): C08B37/00C12P19/04C12N1/20A61K39/09A61P31/04C12R1/46
CPCC08B37/0003C12P19/04C12N1/20A61K39/092A61P31/04
Inventor 苏晓叶王瑞峰林彦彬刘刚朱卫华杜琳
Owner BEIJING ZHIFEI LVZHU BIOPHARM
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