DNA Fingerprinting

DNA fingerprinting is a generic term that corresponds to the use of DNA markers for the assessment of identity.

Identity testing of cell substrates is required under the US general regulations for biological products and the European Pharmacopoeia. The identity of cell lines and the absence of cross contamination between cells must be proven.

Cell lines used to produce recombinant proteins or vaccines must be identified at the level of the species of origin. Classic identity testing of cells used to be done at the protein level with an isoenzyme assay, but since 2009, the EP has rendered mandatory DNA fingerprinting for cell substrates used for the production of vaccines.
DNAVision has developed a DNA fingerprinting method that allows authentification of classic mammalian cell lines at the species level.

Cells used in cell therapy must be identified at the individual level using DNA markers such as microsatellites able to discriminate between cell cultures from different donors.

In thebcase of heterologous treatment, HLA typing can also be performed at the genotype level.

DNAVision uses state-of-the-art technologies applied to genotyping methods for the genetic characterization of biological products or sources in compliance with cGMP requirements.