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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.
Developments in Biological Standardization
|September 24, 1999
Summary
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.