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Oncogenicity & Tumorigenicity Testing

Products manufactured in tumour-derived cell lines and cell substrates have a greater potential for Oncogenicity and Tumourgenicity due to the presence of potential contaminating oncogenes and teratogenic substances. Examples include live viral vaccines, stem cells, and gene therapy viral vectors.

Tumorigenic and oncogenic testing for cell lines includes:

  • In vivo model for tumorigenicity testing (rodent - nude mouse)
  • In vitro soft agarose assay - oncogenicity testing
  • Life-time studies for tumorigenic and oncogenic potential in biopharmaceutical products and substrates
  • Human cell line screening (somatic cell or gene therapy cell lines, human epithelial cells, human cell lines for live virus vaccine production)

Contact an expert about your cell line characterization needs.

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