Genetic Stability Testing

The term genetic stability is applied to the characterization of the cells used in the production of a biologic. The cells have been genetically modified to contain a number of transgene insertion sequences which code for the protein of interest. ICH Guidelines indicate that the stability and integrity of the insertion sequence needs to be characterized to ensure stable production of the correct protein. There are a number of steps which are required to be undertaken to ensure the cell line and production system is acceptable.

There are five techniques which can be applied to the genetic stability of a cell line: DNA Fingerprinting, Southern Blotting, Gene Copy Number, Nucleic Acid Sequencing and Karyology/FISH. These tests are always applied in combination to the characterization of a production cell line. The minimal characterization required is to assess the Master Cell Bank and the End of Production Cell Bank. Testing can also be carried out at other times but is particularly useful where there are changes to the fermentation process. BioOutsource offers the follow genetic stability assays and can advise you on the most appropriate approach for your product:

Contact us to discuss your genetic stability testing requirements.