Plasmid DNA manufacturing expands new service footprint at Eurofins CDMO

Geraldine Buysschaert, Business Unit Manager Biologics Drug Substance, Eurofins CDMO, GeraldineBuysschaert@eurofins.com

Plasmid DNA (pDNA), originating from bacteria, is a small, circular piece of DNA that serves as a versatile tool in genetic engineering applications. Depending on the genes it carries, the plasmid will operate as a template to enable the production of a therapeutic protein or else by functioning as a vehicle for delivering therapeutic genes into cells. pDNA is a key starting material for the production of the viral vectors used in cell & gene therapy, as well as for the in vitro manufacturing of RNA species, like mRNA. Furthermore, pDNA is at the heart of DNA vaccines and non-viral gene therapies.

The growth trajectory of the pDNA market over the past few years has been remarkable and today is mainly driven by the cell and gene sector. With a boost in successful clinical studies and the progress of new therapies across different clinical phases, there is an undeniable need for greater pDNA manufacturing capacity.

To support these rapidly growing fields, Eurofins CDMO in Ghent, Belgium, expanded its service offering with a broadly applicable production platform for pDNA. pDNA manufacturing starts with the fermentation of bacterial host cells, followed by steps for harvest, lysis (to break up the cells and release its content), flocculation (during which suspended particles bind together into larger particles called ‘flocs’), and then clarification (to separate material containing contaminants from the host cells). Next, chromatography is carried out to increase the purity of the pDNA, followed by filtration to concentrate, formulate and fill the product. The resulting bulk solution is subjected to a panel of analytical tests to guarantee the quality and safety of the batch.

Today, the CDMO site in Ghent can support productions for early development stages in shake flasks to manufacturing in a 100-litre stainless steel fermenter for later stages. Efforts are ongoing to release GMP-grade pDNA batches, which is expected in the near future within the current GMP (Good Manufacturing Practice) facility.

The Eurofins network is well positioned in the pDNA market. Activities are typically kicked off with gene design and synthesis, provided by Eurofins Genomics companies. Eurofins CDMO takes the project further along the scale-up and manufacturing phases, supported by the breadth of analytical tests available at Eurofins BioPharma Product Testing. Ongoing development will soon allow Eurofins CDMO to extend its manufacturing support to the cell and gene industry by offering Lipid Nano Particles (LNPs) formulation for pDNA and RNA, as well as manufacturing viral vectors and gene therapies. Undoubtedly, the unique
breadth of the Eurofins network in the pDNA field is a key asset for clients looking for an end-to-end service. For more information, visit: www.eurofins.com/biopharma-services/cdmo/services/biologics-dsdp-development-manufacturing/pdna-manufacturing/ or contact us at: cdmo@eurofins.com