Viral contaminants in cell lines used for the production of biologics products pose a significant risk to human health. Adventitious agents testing is essential when assessing the safety and purity of these products during development.
Regulatory guidelines include adventitious agents testing as part of the routine characterization and qualification of cell substrates and other biological materials used in the production of biopharmaceuticals. Next generation sequencing (NGS) is quickly gaining regulatory agencies’ acceptance as a sensitive and un-biased detection method for adventitious agents.
Working closely with a major US-based pharmaceutical client, Avance Biosciences developed its NGS viral detection work flow that is capable of detecting various viruses (dsDNA, ssDNA, ssRNA, and dsRNA viruses) at low concentrations. Avance Biosciences is positioned to be a strategic partner with our pharmaceutical clients in establishing this powerful tool for testing viral contaminants in cell substrates and biological products.
- Testing adventitious viruses in biological products
- Raw materials
- Final products
- Matrix with viral spike-in
- Testing adventitious viruses in cell substrates
- Cell culture