Testing for Oncogenicity

Oncogenicity is important to ensure that a cell substrate does not contain oncogenic potential. If a vaccine is manufactured in a cell substrate that was derived from a tumor or has a tumorigenic phenotype it could have a higher risk of containing oncogenic substances.  All tumors that develop in oncogenicity assays shall be examined for the presence of DNA from the species that the cell substrate was derived from, and of the animal in which oncogenicity testing was performed. MDS offers Oncogenicity testing of cell lysates and DNA in rats, mice and hamsters.

Our Oncogenicity testing is designed to assure that agents that could immortalize cells and endow them with the capacity to form tumors are not present in a cell substrate. If your vaccine is manufactured in a cell substrate that was derived from a tumor, or that has a tumorigenic phenotype through an unknown mechanism, it might carry a higher theoretical risk of containing oncogenic substances.
If the presence of an oncogenic virus is suspected because of the cell phenotype or the origin of your cell substrate, it is recommended  that you perform oncogenicity testing in animals using lysates of the cell substrate.

MDS offers oncogenicity testing in animals using DNA from the cell substrate for cell substrates with a tumorigenic phenotype, in order to provide assurance that residual DNA is non-oncogenic.   Oncogenicity testing might also be appropriate for some products with high quantities of residual cellular DNA.