When developing biopharmaceuticals, the presence of residual host cell genomic DNA—a process-related impurity—must be measured to demonstrate clearance from biomanufactured therapeutics or vaccines as it can put patient safety at risk. To support this essential testing, ATCC and USP formed a partnership to develop highly characterized and pure genomic DNA analytical reference materials for validating the performance of molecular assays designed to detect and measure residual host cell genomic DNA.

These high-quality reference materials are derived from authenticated host cell lines commonly used in the production of vaccines and biologics. They have been manufactured, evaluated, and quantitated using robust processes, thereby providing effective high-quality controls to help mitigate risk during the development and later, throughout the product lifecycle.