Genetic stability testing of cell banks is a key component of the intracellular analysis required to maintain quality assurance of a production cell line. Furthermore, for regulatory approval of recombinant products, FDA and EMEA both require intracellular demonstration of cell bank quality by analyzing its purity, cell stability, and recombinant DNA gene expression system integrity.
DNAVision provides genetic stability testing services to characterize MCBs (Master Cell Banks), MWCBs (Master Working Cell Banks) and EPCs (End of Production Cells). We can work from bacterial, yeast, and cell cultures.
With genetic stability testing, DNAVision can demonstrate that the expression system has not undergone any genetic modifications (mutations, rearrangements, etc.) which might affect the integrity of the r-DNA product.
We provide a variety of genetic stability tests, from integrated or plasmid cell banks:
The benefits of working with DNAVision SA for your genetic stability testing include:
The client provides:
Notification emails can be sent after completion of each stage of the process. The Final Report includes a description of the overall project design, presentations of raw data and calculation data (when needed. Ex: copy number calculations).
For regulated projects: all working steps in the process flow are documented and filed. Raw data is archived for 20 years. Documentation and certificates are produced by the quality assurance department.
For project needing DNA sequencing: final report includes sequence data (can be delivered in Applied Biosystems trace file format (.abl) or text file format (.seq format)), electropherograms, and assemblies.
For project needing Blotting assay: final reports also include restriction data and Southern blot autoradiographs.
For project needing QPCR assay: the final report also includes ABI 7900HT System output (including experimental reports, standard curves, and amplification plots) and determination of the Ct (amplification threshold value) for each sample.