Host cell DNA services
As biopharmaceuticals are produced within living cells, impurities such as host cell DNA and host cell proteins (HCPs) may arise during the manufacturing process, these are derived from the production system.
Both host cell DNA and proteins pose a risk to patient safety, due to potential oncogenicity, infectivity and immunomodulatory effects. As a result, regulatory agencies have stringent guidelines for safe levels which need to be met before approval.
We offer a range of techniques for the quantitation of host cell DNA, including:
Our scientists are experts in the accurate and sensitive quantitation of host cell DNA impurities, whether encountered at the drug discovery stage or in production.
