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13-valent pneumococcal polysaccharide-protein conjugate composition and preparation method and application thereof

A pneumococcal polysaccharide and pneumococcal technology, applied in the field of 13-valent pneumococcal polysaccharide-protein conjugate composition and its preparation, can solve the problem of affecting the free protein content of carrier protein, affecting the immunogenicity and safety of pneumococcal polysaccharide conjugate And other issues

Active Publication Date: 2018-05-29
云南沃森生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the literature, the purity of the monomers in the tetanus toxoid prepared by the current Pharmacopoeia process is only about 55-70%
However, if tetanus toxoid containing more miscellaneous proteins is used to combine with pneumococcal polysaccharide, it will inevitably affect the effect of the carrier protein and the content of free protein in the conjugate, and then affect the immunogenicity and safety of the pneumococcal polysaccharide conjugate sex

Method used

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  • 13-valent pneumococcal polysaccharide-protein conjugate composition and preparation method and application thereof
  • 13-valent pneumococcal polysaccharide-protein conjugate composition and preparation method and application thereof
  • 13-valent pneumococcal polysaccharide-protein conjugate composition and preparation method and application thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The preparation of embodiment 1 tetanus toxoid carrier protein

[0059] Clostridium tetani with the strain number CMCC 64008 was obtained from the Medical Bacteria Preservation Management Center of the China Institute for the Control of Biological Products. The original seed bank, main generation seed bank and working seed bank were established with the above strains. The original seed batch is the 0th generation, the second generation from the original seed batch is the main generation seed batch, and the second generation from the main generation seed batch is the working seed batch. Start the batch of working seed strains, inoculate in semi-solid medium, 35°C, 48-hour expansion culture, pass three generations to make production seeds. Prepare the tetanus toxin-producing medium according to the formula in Table 1, and use it after high-pressure steam sterilization.

[0060] Table 1 Tetanus toxigenic medium formula

[0061] serial number

Material name ...

Embodiment 2

[0069] Example 2 Degradation of pneumococcal type 1, type 3, type 4, type 5, type 6B, type 7F, type 18C, type 19A polysaccharide

[0070] Pneumococcal type 1, type 3, type 4, type 5, type 6B, type 7F, type 18C, and type 19A polysaccharides were dissolved in 0.2mol / L NaCl to 2-8mg / ml respectively, and prepared as solutions; Pre-cooling in ice bath conditions; ultrasonic treatment in ice bath conditions, ultrasonic power of 350-400W, ultrasonic for 3 seconds, pause for 5 seconds, ultrasonic for 2-20 minutes. Various types of ultrasonic conditions are shown in Table 3.

[0071] Table 3 polysaccharide ultrasonic process parameters

[0072]

Ultrasound time

type 1 polysaccharide

5

type 3 polysaccharide

10

type 4 polysaccharide

8

type 5 polysaccharide

2

Type 6B polysaccharide

6

7F polysaccharide

15

18C polysaccharide

20

19A polysaccharide

12

[0073] Determination of main peak K of pol...

Embodiment 3

[0077] Example 3 Degradation of pneumococcal 6A type, 9V type, 14 type, 19F type, 23F type polysaccharide

[0078] Pneumococcal type 6A, 9V, 14, 19F, and 23F polysaccharides were dissolved in 0.2mol / L NaCl to 2-8mg / ml respectively, and prepared as a solution; they were placed in constant temperature equipment, and the temperature was controlled at 70°C- 85°C, time 0.5-2h, take out and cool naturally. The hydrolysis conditions of each type are shown in Table 5.

[0079] Table 5 polysaccharide hydrolysis process parameters

[0080]

Control temperature(℃)

Hydrolysis time (h)

Type 6A polysaccharide

70

1.5

9V polysaccharide

80

1.0

Type 14 polysaccharide

85

0.5

19F polysaccharide

75

1.0

23F polysaccharide

70

2

[0081] Determination of the main peak K of polysaccharides degraded by high temperature using Sepharose CL-4B XK16 / 100 column D Value, the mobile phase is 0.9% sodium chloride, the flow...

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Abstract

The invention discloses a 13-valent pneumococcal polysaccharide-protein conjugate composition and a preparation method and application thereof. The composition comprises 13 kinds of different pneumococcal polysaccharide-protein conjugates, wherein each pneumococcal polysaccharide-protein conjugate contains capsular polysaccharides and carrier protein from different pneumococcal serotypes, whereinthe capsular polysaccharides derive from type 1, type 3, type 4, type 5, type 6A, type 6B, type 7F, type 9V, type 14, type 18C, type 19A, type 19F and type 23F pneumococci, and the carrier protein isTT of which the monomer purity is greater than or equal to 90%. By virtue of three stages of clinical research and verification, the composition provided by the invention can realize induced production of serotype-specific IgG antibodies for people from 2 months old to 5 years old, wherein after main target crowds from 2 to 6 months old are subjected to three-needle fundamental immunization, the proportion that the concentration of all serotype-specific IgG is greater than or equal to 0.35mu g / ml is greater than or equal to 85%, and after reinforced immunization, the proportion is greater thanor equal to 95%.

Description

technical field [0001] The invention belongs to the technical field of pneumococcal polysaccharide-protein conjugates, and in particular relates to a 13-valent pneumococcal polysaccharide-protein conjugate composition and its preparation method and application. Background technique [0002] Pneumococcus (Streptococcus pneumoniae) is the main cause of meningitis, pneumonia and severe invasive diseases in infants and young children worldwide. According to the "Pneumococcal Vaccine Position Paper" issued by the World Health Organization, WHO predicts that 8.8 million children under the age of 5 will die every year globally. Among them, 476,000 children died due to pneumococcal infection. The morbidity and mortality of pneumococcal disease in developing countries are higher than those in developed countries, and the deaths mainly occur in Africa and Asia. Every year in my country, more than 30,000 infants and young children under the age of 5 die from pneumococcal disease. [...

Claims

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Application Information

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IPC IPC(8): A61K39/116A61K39/385A61K39/09A61P31/04
CPCA61K39/092A61K39/385A61K2039/55505A61K2039/6037A61K2039/70
Inventor 黄镇向左云施競吴凯袁琳方国良陈玉秋钱雯王铭左智洁陈南萍
Owner 云南沃森生物技术股份有限公司
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