Kaneka Eurogentec sets new benchmark in plasmid DNA manufacturing with the production of 1 kg of plasmid DNA.
Image Credit: Kaneka Eurogentec
Attractive cost of goods gives plasmid DNA commercial path forward and positions Kaneka Eurogentec as the premier supplier for plasmid DNA.
Kaneka Eurogentec, an FDA inspected CDMO focused on the production of injectable grade cGMP biopharmaceuticals, announced the manufacture of 1 kg of plasmid DNA, in a single batch, for a major drug development company.
The achievement is remarkable for its efficiency in producing 1 kilogram of plasmid DNA from a single fermentation run. The product quality was confirmed to be above the customer’s specifications and greenlights the commercial supply potential of Kaneka Eurogentec’s cGMP production capability.
Key accomplishments:
- Scale-up of fermentation, lysis and purification technology to kg-scale as a single batch
- Active form of product purified higher than customer’s target specification
- Reduction of supply costs by minimizing purification to a single chromatography step to purify all the plasmid material
This successful production opens commercial opportunities for plasmid DNA drug development companies, both in the field of DNA vaccines and non-viral gene therapy. The efficiency of the production platform changes the economics of launching a plasmid DNA based drug.”
Lieven Janssens, CEO, Kaneka Eurogentec
About plasmid DNA
Plasmid DNA has significant potential for:
- Non-viral gene therapy by delivering specific genes into patient’s cells
- Vaccination by introducing the necessary DNA sequence for antigen production and triggering the necessary humoral and cellular immune response.
- Cancer therapy by delivering cytokines that stimulate the immune system to attack cancer cells, inhibit tumor growth or induce apoptosis in cancer cells.
- Use as a starting material for viral vector and mRNA based therapies.
All plasmid DNA benefit from rapid design, an excellent safety profile, thermal stability and platform manufacturing. The ability to manufacture plasmid DNA at large scale further enhances its potential for clinical advancement and commercial supply.