Genomic DNA Control Materials for Measurement of Residual DNA

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.

DNA analytical reference materials

Cell and Gene Therapies


Vaccines and Proteins

Product: Quantitative HEK-293 Genomic DNA

Product: Quantitative Sf9 Genomic DNA

Product: Quantitative MDCK Genomic DNA

Product: Quantitative MRC-5 Genomic DNA

Product: Quantitative Vero Genomic DNA

Product: Quantitative BHK-21 Genomic DNA


Please refer to our Frequently Asked Questions (FAQs)

Read FAQs

USP Solutions

Learn more about other USP solutions fore each therapeutic modality 

Learn more

ATCC - USP Collaboration
ATCC - USP Collaboration

Learn more about the ATCC-USP Collaboration

Learn more



ATCC-USP Strategic Collaboration

Sign up to learn more and get updates on new products from the ATCC-USP Strategic Collaboration