Full
Outline
To establish the working virus seeds of F-genotype attenuated mumps vaccine SP-A strain in human diploid cells KMB-17.
In cell factory, KMB-17 cells were cultured in MEM medium with 5% newborn bovine serum. After the cells grew to monolayer, the virus was inoculated into 0.020, 0.050 and 0.100 multiplicity of infection (MOI), respectively, in KMB-17 cells. The virus titer was detected everyday, and the optimal MOI and harvest time were determined from the dynamic proliferation curve of virus. The working virus seeds were prepared, the virus titer and thermal stability were determined. Identity, sterility, Mycobacterium Mycoplasma, Adventitious virus and small hydrophobic protein (SH) nucleic acid sequence test were carried out on the working virus seeds. Three batches of experimental vaccine virus harvest and bulk were prepared by using the working virus seeds, and relevant quality control was carried out.
According to the dynamic proliferation curve of virus, optimistic MOI was determined as 0.020, and the best harvest time was 7 days after inoculation. The working virus seeds were prepared according to the optimized procedure. The working virus seeds and three batches of experimental vaccine virus harvest and bulk met the requirements of “Chinese Pharmacopoeia” (Volume Ⅲ, 2020 edition).
The results established procedure of working virus seeds of F-genotype attenuated mumps vaccine SP-A strain, and these data support the subsequent large-scaled preparation of F-genotype attenuated mumps vaccine.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 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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