Cell Line Identity Testing
Analysis of the genome of production cells is one of the most important aspects to show stability and robustness of the cell line. The confirmation of species-level cell line identity is a requirement for the characterization of cell banks which will be used in cGMP manufacturing processes.
Sartorius Stedim BioOutsource offer two methods for confirming cell line identity:
- DNA barcoding assay
- Random Amplified Polymorphic DNA analysis (RAPD)
DNA barcode assay for cell line identity
As part of an ongoing assay improvement programme, we are pleased to introduce a new DNA barcode assay for cGMP cell line characterization testing where species-level identity for mammalian derived cell lines can be determined according to ICH and CBER/FDA regulatory guidelines. The method is already familiar and well understood by the regulatory authorities and is now considered the preferred method for species determination.
The DNA barcoding assay at has been validated for the following cell lines; HeLa, HEK-293, MRC-5, CHO-K1, Vero, A9, MA104 and MDBK.
Random Amplified Polymorphic DNA analysis (RAPD)
An alternative to the DNA barcode assay is the Random Amplified Polymorphic DNA analysis (RAPD), developed and marketed as illustra by GE Healthcare. In this procedure, 6 different primer sets are used to amplify regions of the target genome.
Contact our biosafety scientists today to discuss your cell line identity testing requirements.