Background
Chinese Hamster Ovary (CHO) cells are widely utilized in the biopharmaceutical industry for the production of recombinant proteins like monoclonal antibody (mAb). CHO cells are selected for the high protein yield. In addition, they can perform human-like post-translational modifications which are important for biological activities and stability for therapeutic proteins. However, removal of host cell impurities to a level which is within an acceptable limit is critical for the production of biopharmaceutical products. One concern in the production of recombinant protein is the contamination of the final drug product with residual DNA, arising from host cells. Host cell DNA refers to the genomic DNA from the CHO cells used during production and can carry genes related to viruses or tumors.
Presence of residual DNA in the final drug product can cause adverse events and have serious implications including but not limited to:
• Presence of oncogenic DNA
• Delay in therapy delivery
• Immune response
• Financial loss
• Increased regulatory hurdles
• Time and money wastage due to loss of raw materials and batch products
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