Production of plasmid DNA as starting material for mRNA vaccines

January 15 | 2021
Bielefeld/Germany

How has the importance of plasmid DNA for pharmaceutical applications changed due to the increasing production of gene therapy vectors and COVID-19 mRNA drugs?

Plasmids are used, for example, 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 a starting material for the production of RNA vaccines has become increasingly important, especially in the context of the COVID-19 pandemic situation, 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.

High quality DNA with the requirements to perform as starting material for the production of RNA used in clinical applications

Interview from BioTechnologie Yearbook 2020 with Dr. Martin Schleef, CEO, PlasmidFactory GmbH

What expertise and experience does PlasmidFactory have in the production of plasmid DNA for pharmaceutical application?

Thanks to its 20 years of experience in the field of DNA production, PlasmidFactory has an established process for the production of corresponding plasmid DNA, which fulfils the requirements to be used as a 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 manufacturing 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, patented digestion and 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 (QCs) for the cell bank and plasmid DNA product prior to release. The corresponding QC report is then part of the delivered product alongside the release certificate.

What quality parameters do PlasmidFactory products offer?

In contrast to previously available processes, which were sufficient for the production of plasmid DNA for research in terms of quality and quantity, a process must now be developed that enables plasmids to be produced both in High Quality Grade and in sufficient quantities. Due to the high quality requirements, this represents a considerable challenge that currently needs to be solved in the area of fermentation as well as chromatographic processing of the DNA product. Due to our expertise, particularly in these areas, we see the PlasmidFactory in a pioneering role - we are happy to take on this challenge - very successfully so far!

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