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.
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
- 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
- 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
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.