pDNA manufacturing
The emergence of COVID-19 in recent years, and the consequent global pandemic, accelerated the development and approval of new therapies and vaccines. Plasmid DNA (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 in-vitro transcribed-RNA like mRNA. Furthermore, plasmid DNA is at the heart of DNA vaccines and non-viral gene therapies. For those applications, usually large quantities are required of supercoiled plasmid DNA, the form shown to be effective for biotherapeutic applications.
To support these rapidly growing fields, the Ghent site of Eurofins CDMO expanded its service offering with a broadly applicable production platform for pDNA. Equipped with state-of-the art instruments and building on a solid expertise in microbial fermentation and downstream processing, we are ready to support process development up to large-scale productions of plasmid DNA.
Today, the CDMO site in Ghent can support productions from early development in shake flasks to manufacturing in a 100-litre stainless steel fermenter. Efforts are ongoing to release GMP-grade pDNA batches, which is expected in the near future within the current GMP 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. Undoubtedly, the uniqueness of the Eurofins network in the pDNA field is a key asset for clients looking for an end-to-end service.
