Plasmid DNA Production

We are experts in the production of plasmid DNA and can support your project from pre-clinical through to commercial manufacture. We offer plasmid DNA to the right quality at the right time, no matter if you are working with DNA vaccines, viral vector gene therapies, mRNA or any other modalities.

Applications:

AAV / Lenti vector manufacturing
Non-viral Gene therapy
DNA vaccines
mRNA manufacturing

We offer a range of plasmid qualities, qualities meeting the specific needs for each development phase from early R&D to full GMP. We are using aligned processes ensuring scalability from small to large scale.

GMP Grade

Our GMP grade plasmid is manufactured according to full GMP in qualified clean rooms, are fully QC tested using phase appropriate validated methods. The product is QA reviewed and released by our in house QP. GMP grade plasmid is required for clinical use in application such as DNA vaccines and direct delivered gene therapy but is normally also used for late phase viral vector products

Fully single use process equipment
Fully traceable Non-Animal origin raw materials
RNase free process
Drug Substance quality
GMP level analytics and CoA
EU Release via on site QP
Clinical and commercial scale

High Quality grade

Our High Quality plasmid DNA is suitable for preclinical applications in vitro or in vivo including toxicology studies. High Quality plasmid DNA is manufactured in accordance with regulatory expectations for critical starting material for cell and gene therapies and are used for the manufacturing of viral vectors for clinical use. By utilizing our defined platform technology we provide fast turn around from start to delivered plasmid.