Required measures due to the corona pandemic: Plasmid DNA production on a large scale in High Quality Grade

Plasmid DNA-based vectors are used for the transfer of genetic information into target cells. In addition to its use as an active ingredient to complement genetic defects in the context of cell and gene therapy, DNA-based immunisation, e.g. against viruses, pathogenic germs or tumour tissue (genetic vaccination), the activation of new tissue formation or the support of tissue regeneration are further clinical fields of application for plasmid DNA. The plasmids carry the gene sequences for intracellular production of the coded proteins.

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.