PlasmidFactory has developed a special production process for plasmid DNA (CCC classic grade) which includes the exclusive use of raw materials according to EMA/410/01 rev.3, 2011/C 73/01 (TSE/BSE certificate). Avoiding use of animal-based substances is of importance for clinical applications, since these substances may pose a safety risk. In addition, the use of enzymes is avoided completely during the manufacturing process by removing the RNA chromatographically. At PlasmidFactory, E. coli cultures to amplify plasmid DNA are always carried out in a fermenter and under controlled conditions, because it is not possible to guarantee the reproducibility of the produced biomass when shake flasks are used. The quality of the product is constantly monitored and documented.