Residual DNA Size Analysis Kit-CHO

Biopharmaceutical products, especially monoclonal antibodies and recombinant proteins, are mainly produced using mammalian cell culture systems. Among them, CHO cells are the most commonly used due to their adaptability to a variety of growth conditions, high protein expression levels, and ability to undergo complex post-translational modifications that are essential for the biological function of therapeutic proteins.

However, during the production process, host cell DNA fragments can be purified along with the therapeutic protein. These residual DNA fragments must be strictly quantified and monitored as they may pose a safety risk. If these DNA fragments integrate into the patient's genome or induce an immune response, they may cause insertional mutagenesis, immune responses, or other adverse reactions. Regulatory guidelines from regulatory agencies such as the FDA place strict limits on the amount of residual DNA in biopharmaceutical products, which are usually set at less than 10 ng per dose and DNA size assessments below 200 base pairs. Residual DNA size is a critical parameter because shorter DNA fragments are less likely to cause adverse events than longer fragments.