Plasmid DNA Manufacturing

Plasmid DNA (pDNA) is the vital starting point to produce viral vectors for gene therapies and gene-modified
cell therapies, and for mRNA vaccine and therapies, as well as being used as an API for non-viral gene therapy.

Establishing a reliable and cost-effective source of high quality pDNA, both Critical Reagent Grade or GMP grade, is of critical importance to cell & gene therapy (CGT) companies, and companies producing mRNA vaccines and therapies. Within the CGT field a robust pipeline and increasing capital investment are driving the need for increased plasmid production to support growing CGT and mRNA therapeutics market.

Avantor provides CGT and mRNA biopharma companies with large volumes of high-quality Critical Reagent Grade or GMP plasmid DNA. Produced in a process optimized for high yield of high quality plasmid DNA, this service enables scale up of plasmid DNA and supports speed to market.

This plasmid DNA manufacturing service provides the following:

  • Critical Reagent Grade and full cGMP pDNA from the same supplier
  • Scale up of your plasmid to required volume for your stage of manufacture
  • Various formulations available
  • Appropriate QC, analytical and stability testing conducted
  • Working and master cell bank production available

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Find out more about our pDNA production service for viral vector and mRNA manufacturers

A plasmid is a small, circular double-stranded DNA molecule found in bacteria and other microbes, where it is separate from chromosomal DNA. They typically contain a small number of genes and in nature, they can carry genes that confer advantage to a microbe such as genes for antibiotic resistance.

In CGT and mRNA bioprocessing, synthetic plasmids are spliced to include therapeutic DNA, DNA for building viral vectors, or DNA as a starting material for transcription to mRNA.

In the viral vector production workflow for gene therapies or for genetic modification of cell therapies, plasmids are used to transfect a cell line with the genetic information required to produce a viral vector containing the therapeutic gene of choice. Generally three or four plasmids are used, including structural or ‘helper’ plasmids and a plasmid containing the therapeutic gene of interest.

Additionally, recombinant plasmids can be directly introduced into cells for gene therapy. Plasmid DNA can also be used for ex vivo genetic manipulation of autologous or allogeneic cells, for example to produce CAR T or CAR NK cell therapies. Additionally pDNA it can support in vivo or ex vivo gene editing as plasmid DNA expressing Cas9 and guide RNA required for CRISPR/Cas9 system.

In the mRNA vaccine & therapies workflow plasmid DNA is the template for mRNA production via the linearization and enzymatic in vitro transcription (IVT) reaction. mRNA produced in this can be used to induce the production of a viral protein that then triggers an immune response, in the case of mRNA vaccines, or it can be used to induce cellular production of a protein to replace one that is defective or missing.

Critical Reagent Grade and cGMP pDNA are the two grades of plasmid DNA available through this plasmid DNA manufacturing service. They are both produced using the same starting materials, process, production space and specification.

Critical Reagent Grade plasmid DNA is manufactured in cGMP controlled clean rooms, using validated process equipment. Quality assurance (QA) oversight for Critical Reagent Grade pDNA production includes equipment, facilities and personnel but not the pDNA production process. Documentation provided includes tech transfer documents, material specifications, and Certificate of Testing, which are reviewed by R&D quality team. Critical Reagent Grade offers a high quality but affordable plasmid DNA option.

cGMP grade plasmid DNA is manufactured in the same process as Critical Reagent Grade grade pDNA, but in accordance with all cGMPs. In this case, QA provides oversight of all equipment, facilities, personnel and pDNA production process, with appropriate QA-reviewed documentation batch records and documentation including Certificate of Analysis.