Plasmid DNA Manufacturing
We have a significant experience and expertise in the large-scale production of plasmid DNA for various uses.
We manufacture GMP plasmid DNA starting material to be used in the production of viral vectors (e.g. lentivirus and AAV) or in vitro transcribed-RNA (IVT-RNA) (e.g. mRNA, long RNA)
We also produce plasmid DNA API for use as a DNA Vaccines or therapeutic non-viral plasmid DNA mediated gene therapy applications.
kb plasmid experience
For human clinical trials and commercialization
All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.
Why work with us?
- Experience manufacturing for Phase I, II and III clinical trials
- Plasmid experience from 2.5-16.5 kb
- Numerous antibiotic-free plasmid technologies
- High yielding, high purity proprietary one-chromatography-step purification technology
- 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
- Platform GMP plasmid DNA production, scalable for early clinical to commercial
- Non-animal origin materials
- Batch sizes up to kg scale manufacturing
- Plasmid concentration from 1-15 mg/ml
- High yielding licensed HyperGro® fermentation technology
- High yielding, high purity 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 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.