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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.
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. They are also able to perform both generic HCP assays and validated product-specific HCP assays after proper assay transfer to RSSL.
We offer a range of techniques for the quantitation of host cell DNA and proteins, including:
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