Residual Host Cell DNA Analysis Tools

Residual host cell DNA contamination can be introduced during production of biotherapeutics. Due to the theoretical potential for the transfer of oncogenes from the host cells, regulatory agencies have set allowable limits between 100 pg/dose and 10 ng/dose depending on the cell line used as well as the mode and frequency of dosing. These requirements demand a sensitive method of DNA detection for compliance. Building on its expertise in host cell protein analysis, Cygnus Technologies developed a broad range of residual host cell DNA analysis tools.

• Host Cell DNA Extraction Kits
• Host Cell DNA Detection Kits
• Host Cell DNA Amplification Kits