Plasmids also serve as starting material for the production of viral vectors (AAV, Lenti etc.) and for the production of RNA. In particular, the production of plasmid DNA as starting material for the production of RNA vaccines has become increasingly important, especially in the context of the COVID-19 pandemic, as RNA is considered a promising vaccine candidate for the prevention of certain viral infections and has the advantage of neither integrating into the genome of the cell nor remaining in the patient's body as a potentially effective molecule in the long term.
The PlasmidFactory has a process for the production of corresponding plasmid DNA, which fulfils the requirements to be used as starting material for the production of such RNA used in clinical applications: High Quality Grade Plasmid DNA. This plasmid DNA is produced in a special facility. Starting from a characterised cell bank (RCB), the production process goes through various well-documented production steps. The HQ fermentation plant is physically separated from the purification (chromatography) to ensure that the downstream processing of the sensitive DNA is not affected by live contamination. The proprietary special purification process results in a high level of pure, supercoiled (ccc) plasmid monomers that meet regulatory requirements to form a defined, homogeneous product that undergoes a series of quality controls for the cell bank and plasmid DNA product prior to release.
In contrast to previously available processes, which were qualitatively and quantitatively sufficient for the production of plasmid DNA for research purposes, a process must now be developed through which plasmids can be produced as high quality grade in sufficient quantities. Due to the high quality requirements, this represents a major challenge that currently needs to be solved both in the area of fermentation as well as chromatographic processing of the DNA product. Thanks to its expertise, PlasmidFactory has a pioneering role to play here - a challenge we are happy to take on.
