Gene Copy Number
Gene Copy Number testing
Gene copy number plays a major role in a variety of applications. Some examples are the expression of recombinant proteins in eukaryotic cell lines (characterization of master or working cell banks, clone selection), the development of disease models or the targeted introduction of genes into ATMP products (GTMP). Whether in the context of your R&D activities, as part of a clinical trial or LOT release – the exact knowledge of the gene copy number introduced is critical to the understanding and safety of your therapeutic product and is required by regulatory bodies. We are happy to assist you with the development and validation of qPCR systems, or validate our in-house system for your applications and routine analysis.
Background Information | Gene Copy Number Testing
Lentiviral systems are most frequently used for the transfer of a target genes. These transfer systems are classified according to distribution of viral genes and user safety into generation 1 to 4 systems. Due to the large number of different gene transfer systems and targets, we have developed a system with the widest possible applicability. Here, a host cell gene and a lentiviral gene are quantified in a duplex assay and the gene copy number per host genome is determined. If our system is not or only partially applicable, we will gladly assist you in the development and validation of the missing parts or a corresponding overall system.