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Clonality assurance for existing master cell banks
Is Your Master Cell Bank Monoclonal?
Many cell lines that were developed over 8 years ago were generated using limiting dilution. This procedure is no longer accepted by regulatory authorities. If your cell line was generated using limiting dilution, we can help you confirm that your master cell bank is monoclonal and thereby compliant with regulations.
Collaboration with Cergentis
We conduct the analysis in partnership with Cergentis. ExcellGene will generate dozens of clones from your existing master cell bank, which will then be tested for their genetic composition by Cergentis using their proprietary TLA technology. If all the clones are found to have identical genetic makeup, the master cell bank is considered monoclonal.