RSSL can conduct a wide range of analyses to support the identification of in-process host cell DNA and host cell protein contamination in biopharmaceuticals.

As biopharmaceuticals are produced within living cells, impurities - such as host cell DNA and host cell proteins (HCPs) - may arise during the manufacturing process that 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.