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Issues associated with residual cell-substrate DNA in viral vaccines

Li Sheng-Fowler1, Andrew M Lewis, Keith Peden

  • 1Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drugs Administration, Bethesda, MD 20892, USA.

Biologicals : Journal of the International Association of Biological Standardization
|March 17, 2009
PubMed

Insights

Residual cellular DNA in viral vaccines poses potential oncogenic and infectious risks. New assays quantify these DNA activities, providing worst-case risk estimates for vaccine safety assessments.

Area of Science:

  • Biotechnology
  • Vaccinology
  • Molecular Biology

Background:

  • Viral vaccines may contain residual cellular DNA from production cell substrates.
  • The safety implications of this DNA, especially from tumor-derived cells, are not fully understood.
  • Cellular DNA possesses oncogenic and infectious biological activities.

Purpose of the Study:

  • To assess the safety risks associated with residual cellular DNA in viral vaccines.
  • To develop and validate assays for quantifying the biological activities of DNA.
  • To estimate the potential oncogenic and infectious risks posed by residual DNA.

Main Methods:

  • Development of sensitive assays to quantify DNA's oncogenic and infectious activities.
  • Estimation of worst-case risks based on the most sensitive assay data.
  • Evaluation of methods to inactivate DNA's biological activities.

Main Results:

  • Established assays can quantify the biological activities of residual cellular DNA.
  • Risk estimations for oncogenic or infectious events from DNA were determined.
  • Methods for reducing DNA's biological activities were assessed.

Conclusions:

  • Quantifiable assays provide a basis for assessing residual DNA risks in viral vaccines.
  • Worst-case risk estimates inform vaccine safety evaluations.
  • Methods exist to mitigate the biological activities of cellular DNA in vaccines.

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