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Quality evaluation of Japanese encephalitis inactivated vaccine strain in human diploid cells
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Hong-shan XU1, Hui-li SHEN2, Rui FU1, Xin-yu LIU1, *, Yu-hua LI1, Qiang YE1
Chinese Journal of Pharmaceutical Analysis | 2024, 44(3) : 542 - 546
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Chinese Journal of Pharmaceutical Analysis | 2024, 44(3): 542-546
Quality Control
Quality evaluation of Japanese encephalitis inactivated vaccine strain in human diploid cells
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Hong-shan XU1, Hui-li SHEN2, Rui FU1, Xin-yu LIU1, *, Yu-hua LI1, Qiang YE1
Affiliations
  • 1.National Institutes for Food and Drug Control,Beijing 102629,China
  • 2.Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,Hefei 230088,China
Published: 2024-03-31 doi: 10.16155/j.0254-1793.2024.03.20
Outline
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Objective:

To evaluate the quality of the Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3).

Methods:

The virus strain was identified by identification test to determine whether it was Japanese encephalitis virus strain,the virus titer was tested in mice brain to evaluate the adaptability and proliferation ability of the virus seed on human diploid cells (ZFB-3),the sterility test,mycoplasma test,and external virus factor test was conducted for any external contamination.

Results:

The virus strain was proved as Japanese encephalitis virus and had been well adapted to human diploid cells (ZFB-3) with high virus titer. The virus strain was free from contamination by bacteria,fungi,mycoplasma or exogenous viral factors.

Conclusion:

The quality of Japanese encephalitis inactivated vaccine strain adapted in human diploid cells (ZFB-3) meets the requirements and can be applied to vaccine production.

Japanese encephalitis virus  /  inactivated vaccines  /  human diploid cells  /  virus strain  /  quality evaluation
Hong-shan XU, Hui-li SHEN, Rui FU, Xin-yu LIU, Yu-hua LI, Qiang YE. Quality evaluation of Japanese encephalitis inactivated vaccine strain in human diploid cells[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (3) : 542 -546 . DOI: 10.16155/j.0254-1793.2024.03.20
Year 2024 volume 44 Issue 3
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Article Info
doi: 10.16155/j.0254-1793.2024.03.20
  • Receive Date:2023-11-22
  • Online Date:2026-03-13
  • Published:2024-03-31
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  • Received:2023-11-22
Affiliations
    1.National Institutes for Food and Drug Control,Beijing 102629,China
    2.Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.,Hefei 230088,China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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