Cell Line Development
Cell lines such as Chinese Hamster Ovary (CHO) cells are used in the development and production of therapeutic proteins. Ensuring correct genetic engineering is important in various stages of cell line development.
Cergentis' cutting-edge Targeted Locus Amplification (TLA) technology is widely used in all stages of cell line development, empowering:
- Optimization and validation of new cell line generation technologies
- Identifying integration hotspots
- Clone selection
- Cell line characterization
- Clonality assurance
- Genetic stability analyses
Cergentis routinely supports the majority of leading pharmaceutical companies in their (CHO) cell line development process. Through this, we have established our position as a trusted partner in the genetic analysis of genetically engineered pharmaceutical cell lines. Our team has in-depth experience analyzing genetic alterations in various forms. Moreover, we offer detailed reporting suitable for use in the regulatory application for pharmaceuticals for human use, according to FDA and EMA expectations (CTD Quality module, section 3.2.S.2.3.).
TLA analyses identify:
- Genomic position(s) of transgene integration(s)
- Single nucleotide variants in transgene sequence
- Structural changes in transgene and integration site(s)
- Genetic alterations resulting from targeted (trans)gene editing
In addition to TLA, Cergentis offers a portfolio of services to further characterize your candidate cell bank, including:
- Plasmid or vector sequencing
- Genotyping primer design
- Clonality Assurance Package
- Genetic Stability Package
- Premium Package
For more information on our services and how we may support your project, please contact our sales team.