BioPharmaceutical manufacturing
GMP Plasmid DNA
We have over 30 years of expertise in microbial fermentation, including 20 years as a CDMO specializing in GMP-grade plasmid DNA production. Operating from our FDA-inspected facilities in Belgium, we combine scientific expertise with certified project management to support the success of your therapeutic programs.
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.
Starting Material
Eurogentec is a trusted partner for the GMP production of Plasmid DNA used as Starting Material. Our plasmids are used in mRNA synthesis and viral vector manufacturing, and are already contributing to the commercial supply of several FDA approved cell and gene therapy drugs.
Active Pharmaceutical Ingredients (APIs)
We manufacture GMP plasmid DNA for API applications in DNA vaccines and non-viral gene therapies. Our optimized high-yield process enables batch production over 1 kg, confirming our position as a global leader in GMP pDNA manufacturing.
New benchmark in
plasmid DNA manufacturing
1 kg of plasmid DNA in a single batch, for a major drug development company.
De-risk your journey from tox studies
to commercialization
We support your journey from tox studies to full commercial supply. Whether you are conducting
toxicology studies, entering Phase I/II clinical trials, or advancing toward commercialization, our
team ensures seamless project continuity and regulatory compliance at every stage.
Optimized GMP process
Our GMP-compliant process is designed to adapt to your project while ensuring high yields and
reducing manufacturing Cost of Goods Sold (COGS). From master cell bank production to final
product delivery, we maintain the highest quality standards and provide all required testing and
documentation to support smooth regulatory approval.
High-yield proprietary process applied from start to finish
Our process development approach supports every stage of GMP plasmid DNA manufacturing, from cell banking to final product. Built on a proprietary and adaptable platform, it ensures consistency, performance, and scalability across the entire production workflow.
Key features of our adaptable GMP process include
- Non-animal origin materials
- Plasmid sizes from 1.5 - 20.0 kbp
- High-yield
- Cost-effective GMP plasmid DNA production
Our master cell bank service includes
- Use of the cell bank provided by the client
- Or manufacturing of an E. coli master cell bank, and its characterization and stability testing
What defines our GMP fermentation approach
- High yielding licensed HyperGro® fermentation technology
- Scalable quantity from 80 L to 2200 L
- Batch sizes from 1g to kg scale manufacturing
Lysis process built for efficiency
- Optimized scalable proprietary process
What defines our high-efficiency purification platform
- Proprietary one-chromatography-step purification technology
- High yield
- High purity
- Above FDA quality requirements
Final product release supported by fully compliant documentation
- Quality review
- Manufacturing report
- CoA
- TSE/BSE-free statement
- GMP statement
- Client-specific batch record
- Formal stability studies (ICH)
QC Release
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. With an FDA Drug Master File (DMF) on record,
we simplify your CMC dossier submissions and accelerate regulatory pathways. Furthermore,
our batch release testing is fully aligned with current GMP regulatory standards.
| Attributes | Testing |
| Identity | Restriction mapping DNA sequencing |
| Content | DNA concentration by UV (A260) |
| Purity | Plasmid topology by HPLC or CGE UV Ratio 260/280 |
| Safety | Bioburden Endotoxin content by LAL kinetic method Mycoplasma detection* |
| Residuals | Host Cell Proteins by ELISA Residual Host Cell genomic DNA Host cell RNA by HPLC (limit test) Host cell genomic DNA by qPCR Antifoam by ICP/MS Antibiotic by RP-HPLC-MS* |
| Physico-chemical | Visible particles* Appearance (instrumental methods or visual inspection) pH Osmolality* |
| *test on demand |
Your GMP-accredited CDMO
Every aspect of our manufacturing environment is designed to support the success of your pDNA
project. From GMP-certified facilities and state-of-the-art equipment to highly trained staff and
certified project management, we combine technical excellence with operational transparency.
Why work with Eurogentec?
Dedicated project management
Thanks to our certified project manager, we ensure transparency and collaboration all along your project to deliver your pDNA product on time.
cGMP manufacturing
From cell bank to final purified plasmid, your pDNA will be produced under stringent GMP conditions in our state-of-the-art US FDA inspected facilities located in Belgium.
Comprehensive documentation
Our GMP pDNA services include full documentation panel necessary for the good progression of your project such as CoA, CoQ, TSE/BSE statements & batch records.
Regulatory Support
With our extensive experience, our team of experts will assist you in preparing your regulatory files (e.g. IND).
On time delivery
Count on our tightly controlled GMP workflow and expert planning to deliver your plasmid DNA on time, from project start to final delivery.
Multi-purpose platform
Our GMP platform supports multiple applications, delivering plasmid DNA both as Starting Material and as API to match the needs of your development phase.
