Plasmid DNA Manufacturing

We have a significant experience and expertise in the large-scale production of plasmid DNA for various therapeutic development strategies.

GMP plasmid DNA can be used as starting materials by companies which manufacture ATMPs (advanced therapy medicinal products) such as viral vectors (e.g. lentivirus and AAV) or in vitro transcribed-RNA (IVT-RNA) (e.g. mRNA, long RNA)

Plasmid DNA can also be the active pharmaceutical ingredient we deliver to Pharmaceutical companies. It can be used as the active component of their drug product.

kb plasmid experience

Small & large scales GMP Plasmid DNA

All GMP material is produced in our facilities in Belgium in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH.

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Small-scale GMP Plasmid DNA

With our small-scale plasmid production service, we provide up to grams of GMP biopharmaceuticals.

We deliver enough quantity of GMP material to perform clinical trial phases 1 and 2.

GMP Plasmids are manufactured in one of our GMP fermentation suites equipped with fermenters from 80 to 150 Liters.

Large-scale GMP Plasmid DNA

Our scalable approach allows us to accompany our customers through all stages of their process.

Our fermentation experts have optimized the production process performance of plasmid DNA in E.coli.

Combined with our 2200L fermenter, they succeed to produce up to the kilo-scale plasmid DNA in a single batch.

Why work with us?


  • GMP Manufacturing experience since 1994
  • Plasmid sizes from 2.5-16.5 kb
  • Numerous antibiotic-free plasmid technologies
  • High yielding, high purity proprietary one-chromatography-step purification technology above FDA quality requirements

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  • Manufacturing in US FDA inspected facility, inspected 2011, 2013, 2014 & 2017
  • Drug Master File (DMF) in place with US FDA for easy CMC dossier submission
  • Scalable quantity compatible with clinical trials and commercial needs
  • Non-animal origin materials

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  • Batch sizes from 1g to kg scale manufacturing
  • Plasmid concentration from 1-10 mg/ml
  • High yielding licensed HyperGro® fermentation technology
  • Proprietary one-chromatography-step purification technology yielding plasmid DNA exceeding FDA quality guidelines

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Scalable process from g to kg

Plasmid manufacturing from 80L to 2200L scale

We manufacture GMP plasmid up to the kg scale with lower quantities of raw materials, volumes of solvents and waste.

We currently manufacturing plasmid DNA for big pharma companies worldwide.

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Non-viral DNA vector

We offer expertise in non-viral DNA vector development and GMP manufacturing.

We have already achieved the production of plasmid DNA API at the 200g scale using a 350L working volume fermenter with plans to scale-up to kg-scale.

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Starting Materials

We have experience in the production and quality control of difficult to produce plasmid DNA such as sequences that contain duplicate genes of interest, inverted terminal repeats (ITR), long terminal repeats (LTR) or polyA tails.

Our very large-scale plasmid manufacturing capabilities are particularly interesting for the reduction of cost of goods for helper plasmids that can be used in multiple viral vector production projects.

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