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Experience with vero cells at Pasteur Mérieux Connaught
B J Montagnon1, J C Vincent-Falquet, J F Saluzzo
1Pasteur Mérieux Connaught, Marcy l'Etoile, France.
Abstract:
The Vero cell line has been used by Pasteur-Merieux-Connaught (PMC) since 1982 with the Cell Bank's system to produce, at the 142nd passage, inactivated polio vaccine (IPV), oral polio vaccine (OPV) and rabies vaccines. The safety of the cell line has been regularly validated at the WCB level according to the WHO and European Pharmacopeia requirements for absence of bacteria, fungi, mycoplasma and viruses. Special emphasis was devoted to establishing the absence of simian viruses (SV40, SIV, Retro-D virus, simian CMV). Reverse Transcriptase (RT) activity was also negative. At low level of passage, the Vero cells are not tumorigenic. Vaccines have been prepared in low passage level Vero cells and, together with the excellent downstream purification, has resulted in excellent safety as attested by pharmacovigilance of more than 100 million doses of IPV during 12 years, more than 20 million doses of rabies vaccine during 10 years and more than one billion of OPV during six years.
Insights
Vero cells, used since 1982 for vaccine production, have undergone rigorous safety testing. Extensive pharmacovigilance confirms the excellent safety profile of vaccines derived from these cells.
Area of Science:
- Biotechnology
- Vaccinology
- Cell line characterization
Background:
- Vero cell line utilized by Pasteur-Merieux-Connaught (PMC) since 1982 for vaccine production.
- Established Cell Bank system for consistent vaccine manufacturing.
Purpose of the Study:
- To detail the safety validation of the Vero cell line for vaccine production.
- To present pharmacovigilance data supporting vaccine safety.
Main Methods:
- Regular safety validation of Vero cells according to WHO and European Pharmacopeia standards.
- Testing for absence of microbial and viral contamination, including specific simian viruses.
- Assessment of tumorigenicity at low passage levels.
Main Results:
- Vero cells consistently met safety requirements, with no detected bacteria, fungi, mycoplasma, or viruses.
- Absence of specific simian viruses (SV40, SIV, Retro-D, simian CMV) and negative Reverse Transcriptase (RT) activity.
- Low passage Vero cells demonstrated non-tumorigenic properties.
Conclusions:
- Vero cell line is safe for producing inactivated polio vaccine (IPV), oral polio vaccine (OPV), and rabies vaccines.
- Combined cell line safety and downstream purification ensure excellent vaccine safety.
- Extensive pharmacovigilance data support the safety of vaccines produced using Vero cells.