BioPharmaceuticals Production
GMP Plasmid DNA Manufacturing
We produce GMP Plasmid DNA for starting material, or API since 2004.
We have developed a platform production process that provides GMP grade plasmid in scales from gram to kilogram that is recognized by numerous big pharma companies for quality and scalability.
Get a quick view of our services
Watch our video to discover our facilities and how we can help you advancing your pDNA drug development journey.
All-in-one GMP pDNA solution
We provides GMP plasmid DNA solutions to support different stages of your therapeutic development.
Whether used as Starting Material or as an Active Pharmaceutical Ingredient (API),
our GMP pDNA are manufactured to meet stringent regulatory requirements.
Innovative scalable process
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.
Experience
- Plasmid experience from 2.5-16.5 kb
- Numerous antibiotic-free plasmid technologies
- High yielding, high purity proprietary one-chromatography-step purification technology
Quality
- 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
Quantity
- 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
