A CHO cell or Escherichia coli is used as a host cell for expression of antibodies or proteins in the manufacturing process of biopharmaceuticals. As DNA of these host cells may cause tumor formation, it is necessary to control the DNA as a process-related impurity.
Guidelines of the World Health Organization (WHO), the United States Food and Drug Administration (USFDA), and the European Pharmacopoeia (EP) state that the final amount of host residual DNA should be less than 100 pg/dose, or even as little as 10 ng/dose.
FUJIFILM Wako Pure Chemical Corporation offers a DNA extraction and purification kit, "DNA Extractor® Kit," as a reagent for residual DNA testing.