Evaluation of cellular substrates used in research and production of biological products for infection with BVDV 1 & 2

Document Type : Full Research Paper

Authors

1 Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj

2 Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran

Abstract

Simultaneously with the expansion of vaccine production on cell culture media, identification and elimination of adventitious viruses infecting culture media of animal origin, as well as prevention of contamination of biological products from cell culture media to one of the main concerns of production Vaccine suppliers. The aim of this study was to investigate the possible contamination of cellular substrates used in research and production of biological products of Razi Vaccine and Serum Research Institute with BVD1 and BVD2 viruses. The address of this investigate was 44 samples from 44 cell lines with different passage numbers and storage dates in a total of 100 samples. After extracting RNA from the above cells, a screening test was performed using Real Time PCR and a pair of primers to identify all Pestivirus. In this experiment, the cytopathic biotype BVDV1a NADL was used as a positive control. Then the species and their subspecies were determined by RT-PCR method. Infection was observed in five cells Hek293, IBRS2, RBK, FLK, RK13, all cells except IBRS2 in BVDV1b typing. All of these cells are used in research and quality control of biological products.

Keywords

References

1. Marcus-Sekura, C., et al., Evaluation of the Human Host Range of Bovine and Porcine Viruses that may Contaminate Bovine Serum and Porcine Trypsin Used in the Manufacture of Biological Products. Biologicals : journal of the International Association of Biological Standardization, 2011. 39(6): p. 359-369.
2. Rebecca Sheets , J.L., Gopa Raychaudhuri , John Petricciani, Adventitious agents, new technology, and risk assessment, 19e20 May 2011, Baltimore, MD. Biologicals, 2012. 40: p. 162-167.
3. Ranjbar, M. M., M. M. Ebrahimi, S. Shahsavandi, T. Farhadi, A. Mirjalili, M. Tebianian and M. H. Motedayen. 2019. Novel Applications of Immuno-bioinformatics in Vaccine and Bio-product Developments at Research Institutes. Archives of Razi Institute. 74: 219-233.
4. Sheets, R., et al., Adventitious agents, new technology, and risk assessment, 19–20 May 2011, Baltimore, MD. Biologicals, 2012. 40(2): p. 162-167.
5. Farsang, A. and G. Kulcsar, Extraneous agent detection in vaccines--a review of technical aspects. Biologicals, 2012. 40(4): p. 225-30.
6. Dodet, B., et al., Viral safety and extraneous agents testing for veterinary vaccines. Biologicals, 2010. 38(3): p. 326-331.
7. Bruckner, L., Viral safety and extraneous agents testing for veterinary vaccines: Rationale for requirements, the European approach. Biologicals, 2010. 38(3): p. 338-339.
8. Nicklas, W., V. Kraft, and B. Meyer, Contamination of transplantable tumors, cell lines, and monoclonal antibodies with rodent viruses. Lab Anim Sci, 1993. 43(4): p. 296-300.
9. Bauermann, F.V., et al., HoBi-like viruses: an emerging group of pestiviruses. Journal of Veterinary Diagnostic Investigation, 2013. 25(1): p. 6-15.
10. Kirkland, P., et al., Identification of a novel virus in pigs—Bungowannah virus: a possible new species of pestivirus. Virus research, 2007. 129(1): p. 26-34.
11. Schirrmeier, H., et al., Genetic and antigenic characterization of an atypical pestivirus isolate, a putative member of a novel pestivirus species. Journal of General Virology, 2004. 85(12): p. 3647-3652.
12. Vilcek, S., et al., Characterization of a novel pestivirus originating from a pronghorn antelope. Virus research, 2005. 108(1-2): p. 187-193.
13. Hayflick, L., History of the development of human diploid cell strains (Opatija) in Proceedings, symposium on the characterization and uses of human diploid cell strains. 37- 54, 1963.
14. WHO, Requirements for Poliomyelitis Vaccine (Inactivated). In Requirements for Biological Substances: 1. General Requirements for Manufacturing Establishments and Control Laboratories; 2. Requirements for Poliomyelitis Vaccine (Inactivated). Report of a Study Group. In WHO Technical Report Series No. 178, World Health Organization, Geneva. 1959.
15. Hayflick, L., A brief history of cell substrates used for the preparation of human biologicals. Dev Biol, 2001. 106: p. 5-23.
16. WHO, Requirements for Poliomyelitis Vaccine (Oral). In Requirements for Biological Substances . In WHO Technical Report Series No. 486, World Health Organization,Geneva. No.7.
17. Symp, Proc Symp on Human Diploid Cell. Suggested methods for the management and testing of diploid cell culture used for virus vaccine production. Yugoslav Academy of Sciences and Art, Zagreb. P 213-216. 1970.
18. Tarmakova, S. S., S. Y. Sanzhieva and E. S. Nikolaeva. 2019. Impact of Phytobacterial Agent on the Toxic Damage to the Liver and Ileum of White Rats. Archives of Razi Institute. 74: 287-294.
19. Yolken, R., et al., Infantile gastroenteritis associated with excretion of pestivirus antigens. The Lancet, 1989. 333(8637): p. 517-520.
20. Yolken, R. Pestivirus infection in identicai twins discordant for schizophrenia. in Proceedings of the IXth Congress of Virology, Glasgow. 1993.
21. Potts, B., et al., Possible role of pestiviruses in microcephaly. The Lancet, 1987. 329(8539): p. 972-973.

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History

  • Receive Date: 22 August 2020
  • Revise Date: 08 September 2020
  • Accept Date: 10 September 2020

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