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Related Experiment Videos

Experience with the Vero cell line

B J Montagnon1, J C Vincent-Falquet

  • 1Pasteur Mérieux Sérums & Vaccins, Marcy L'Etoile, France.

Developments in Biological Standardization
|September 16, 1998
PubMed
Summary
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The Vero cell line, used since 1982 for vaccine production, has demonstrated consistent safety and efficacy. Rigorous testing confirmed the absence of contaminants, ensuring the safety of inactivated polio vaccine (IPV), oral polio vaccine (OPV), and rabies vaccines.

Area of Science:

  • Vaccinology and Cell Line Technology
  • Microbiology and Virology
  • Biopharmaceutical Manufacturing

Background:

  • The Vero cell line has been a cornerstone for vaccine production since 1982.
  • Pasteur Mérieux Serums & Vaccins (PMsv) has utilized Vero cells for inactivated polio vaccine (IPV), oral polio vaccine (OPV), and rabies vaccine manufacturing.
  • Cell bank management and rigorous safety testing are critical for vaccine production.

Purpose of the Study:

  • To detail the safety validation processes for the Vero cell line used in vaccine production.
  • To confirm the absence of adventitious agents, including specific simian viruses, in the Vero cell line.
  • To provide evidence of the long-term safety and efficacy of vaccines produced using the Vero cell line.

Main Methods:

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  • Vero cell line management through a Cell Bank system up to the 142nd passage.
  • Routine safety validation at the Working Cell Bank (WCB) level adhering to WHO and European Pharmacopoeia standards.
  • Specific testing for bacteria, fungi, mycoplasma, viruses, including simian viruses (SV40, SIV, Retro-D, simian CMV).

    • Main Results:

    • All safety tests, including those for bacteria, fungi, mycoplasma, and specific simian viruses, yielded negative results.
    • Vero cells at low passage levels were confirmed to be non-tumorigenic.
    • Extensive pharmacovigilance data from over 100 million doses of IPV, 20 million doses of rabies vaccine, and over 1 billion doses of OPV support the safety profile.

    Conclusions:

    • The Vero cell line, when managed under stringent controls and tested rigorously, provides a safe substrate for vaccine production.
    • The validated safety of the Vero cell line, combined with effective downstream purification, ensures the safety of manufactured IPV, OPV, and rabies vaccines.
    • Long-term pharmacovigilance confirms the excellent safety record of vaccines produced using this cell line, supporting its continued use in public health.