Time filter

Source Type

He R.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | Cui Y.-P.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | Qi F.-C.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | Zhou T.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | And 6 more authors.
Chinese Journal of Biologicals | Year: 2015

Objective To analyze the complete genome sequence as well as antigenicity and immunogenicity of rabies vims (RV) PV-2061 strain. Methods The complete genome sequence of strain PV-2061 was amplified fractionally by RT-PCR and cloned into pMI) 18-T Simple Vector separately. The constructed recombinant plasmids were transformed to E. coli TOP 10, and positive clones were screened and sequenced. The sequencing results were spliced and analyzed by using DNAstar MegAlign software. Strain PV-2061 was analyzed for antigenicity by ELISA, and for immunogenicity by immunizing mice with the vaccine prepared with virus seeds from master seed lot. Results The genome of strain PV-2061, at a full-length of 11 932 bp, consisted of five structural genes, N, P, M, L and G, and arranged in turn from 3′-to 5′-tenninuses. Each gene was constituted of non-coding regions from 3′-to 5′-terminuses and coding regions in the middle part. Compared with those of strains with known complete genome sequences in GenBank, the 3′-terminal front pilot sequence and the non-coding regions of N gene showed no change in length, while showed change from P gene, resulting in the difference in lengths of genomes of various strains. The antigen content of strain PV-2061 was 7.46 IU/ml, while the protection index of vaccine prepared from master seeds was 1 585. Conclusion The complete genome sequence of PV-2061 strain was determined as genotype 1, which showed RV-specific antigenicity and good immunogenicity. It provided an experimental basis for design of rabies vaccine and screening of virus strains.


Cui Y.-P.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | He R.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | Qi F.-C.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | He X.-Y.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. | And 5 more authors.
Chinese Journal of Biologicals | Year: 2014

Objective: To evaluate the effect of non-restriction endonuclease in removal of Vero cell DNA in rabies vaccine. Methods: The harvested rabies virus liquid was treated with non-restriction endonuclease at various concentrations in PBS or Tris buffer at various temperatures for various hours, and purified by molecular sieve chromatography, then determined for residual DNA content by DIG high prime DNA labeling and detection kit. The residual endonuclease level in harvested rabies virus liquid under the determined condition for treatment was determined by Benzonase ELISA kit II. The antigen content was determined by ELISA. Results: The concentration of non-restriction endonuclease for treatment was 50 - 90 U / ml, while BPS or Tris was used as buffer system. The removal rate of Vero cell DNA in harvested rabies virus liquid after treatment at 37 °C for 2 - 3 h, further treatment 18 - 26 °C for 12 - 18 h and purification by molecular sieve chromatography was more than 80%, while the recovery rate of virus antigen was more than 75%. Rabies virus and Benzomnase was effectively separated under the determined condition for treatment. Conclusion: The Vero cell DNA in rabies vaccine may be removed effectively by non-restriction endonuclease.


Qi F.-C.,Jiangsu Simcere Vaxtec Bio Pharmaceutical Co.
Chinese Journal of Biologicals | Year: 2014

Objective: To evaluate the safety of rabies vaccine prepared by degradation of Vero cell DNA with Benzonase in animals. Methods: According to the Technical Guideline for Irritation, A anphylaxis and Haemolysis of Chemical Drugs, the freeze-dried rabies vaccine (Vero cells) for human use after treatment with Benzonase was subjected to systemic active anaphylaxis test and in vitro hemolysis test in guinea pigs, acute toxicity test in rats and muscle stimulation test in rabbits to evaluate the safety. Results: The incidence of anaphylactic reactions of the vaccine in guinea pigs was 50% and the animals with reactions were recovered to normal 5 min later. The result of hemolysis test was negative. No abnormality was observed in acute toxicity test. Extremely mild or mild interstitial inflammatory cell infiltration, musculature degeneration and necrosis as well as desmoplasia were observed in injection sites of rabbits, of which the degrees were relieved 2 weeks later. Conclusion: The rabies vaccine prepared by degradation of Vero cell DNA with Benzonase, with a residual Benzonase content of less than 0.2 ng/ml, showed high safety and was suitable for clinical application.

Loading Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. collaborators
Loading Jiangsu Simcere Vaxtec Bio Pharmaceutical Co. collaborators