Group items tagged

Host cell residual DNA refers to the small amount of nucleic acid (host genome, plasmid, or total DNA) that remains in protein drugs expressed and purified through cell culture. During the production process of expressing antibody protein drugs, a large number of cells undergo proliferation and amplification, and some aging cells die and lyse, releasing a large amount of genomic DNA. This leads to the presence of a large amount of free host cell DNA in the cell culture harvest of recombinant biologics, and a small part of the host cell DNA is removed during the processing steps (such as acid precipitation, filtration, etc.), while most of it is removed during the anion exchange chromatography step. Finally, there is a trace amount of host cell residual DNA in the original solution of the recombinant protein drug.