The production of high quality plasmid DNA ...
... as a starting material for the production of RNA vaccines has gained importance, especially in connection with the COVID-19 pandemic. As a promising vaccine candidate for the prevention of certain viral infections, RNA has the advantage of not integrating into the genome of the cell.
PlasmidFactory has developed and established the process for the production of the corresponding plasmid DNA. And we are now able to provide our products in large quantities!
How has the importance of plasmid DNA for pharmaceutical applications changed due to the increasing production of gene therapy vectors and COVID-19 mRNA agents?
Plasmids serve, 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 very important, especially in light of the COVID-19 pandemic situation, since 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 body of a patient as a potentially effective molecule in the long term.
What expertise and experience does PlasmidFactory have in producing plasmid DNA for pharmaceutical use?
With its now 23 years of experience in the field of DNA production, PlasmidFactory has an established process for the production of appropriate plasmid DNA, which meets the requirements to be used as starting material for the production of such RNA used in clinical applications: High Quality Grade Plasmid DNA. This high quality plasmid DNA is produced in a special facility: Starting from a characterized cell bank (RCB), the manufacturing process goes through several well-documented production steps. The HQ fermentation facility is spatially separated from the purification (chromatography) to ensure that the downstream processing of the sensitive DNA is not affected by live contaminants. The proprietary special patented 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 cell bank and plasmid DNA product quality controls (QCs) prior to release. The corresponding QC report is then part of the delivered product, along with the release certificate.
What quality parameters do PlasmidFactory products offer?
In contrast to previously available processes, which were qualitatively and quantitatively sufficient for the production of plasmid DNA for research, a process must or had to be created now by which plasmids can be produced both in High Quality Grade HQ quality and in sufficient quantities. Due to the high quality requirements, this represents a considerable challenge, which currently has to be solved both in the area of fermentation and with regard to the chromatographic processing of the DNA product. Due to our expertise, especially in these areas, we see the PlasmidFactory in a pioneering role - we are happy to meet this challenge - so far very successfully!
Large Scale Information
Keeping polyAs intact
We make use of PlasmidFactory‘s proprietary POLYARESCUE® technology to amplify plasmid DNA containing long polyA stretches
PlasmidFactory has developed and established the process for the large-scale production of the corresponding plasmid DNA.
Minicircle – a safe and highly efficient vector system
Minicircles (MC) are circular DNA molecules that are generated by an intramolecular (cis-) recombination from a parental plasmid (PP). The difference between MC and standard plasmid vectors for gene therapy or nucleic acid vaccination is that the MC contains neither the bacterial origin of replication (needed only in bacteria for the amplification of plasmids in cell division) nor the antibiotic resistance markers or other selection systems.
Hence, minicircles are the most promising tools to achieve both, increased efficacy as well as regulatory requirements for future clinical applications.
PlasmidFactory is the exclusive owner of relevant patents and IP in this field and provides service production of these supercoiled monomeric constructs, according to clients’ requirements.
In Stock service
Besides individual productions plasmids and minicircles are provided from PlasmidFactory´s In Stock Service: AAV plasmids (e.g. Helper & Packaging plasmids of the pDG/pDPfamily, several serotypes and GFP vector plasmids), reporter genes (gfp, lacZ, luc), and pEPIplasmids (containing S/MAR elements).
PlasmidFactory´s In Stock products that are deliverable immediately “off-the-shelf”.