Cell Line Characterization

Extensive cell line characterization is required for mammalian, microbial and insect cell substrates used to generate biopharmaceuticals. This includes phenotypic or genotypic identity testing and a broad range of adventitious agents testing.

Cell Line Characterization & Authentication Methods

Cell line characterization package recommendations depend on the species of the cell line (e.g., hamster, human, chicken, E. coli, P. pastoris) and its intended use (e.g., recombinant protein production, vaccine production, gene therapy). Furthermore, documentation of the source of the cell line and its development history, as well as the biological properties of the cells, determines which testing should be performed. When executing the assays, the guidelines recommend using testing procedures that are validated to show their suitability for the intended purpose. With all of these considerations, it is important to partner with experienced companies to determine the most effective and efficient cell line characterization plan.

Services

• Microbial & Mammalian Cell Line Characterization
• Genetic Stability
• In Vivo Biosafety Testing