Pre-Clinical Plasmid DNA
High Quality Plasmid DNA for Every Phase of Pre-Clinical Research
With twenty years of plasmid DNA manufacturing and production expertise and patented manufacturing technology, VGXI delivers plasmid production services at different compliance levels for a full spectrum of applications ranging from research to commercial supply.
VGXI’s Pre-Clinical Plasmid DNA Production Service offers high purity, low endotoxin plasmid DNA specifically designed for pre-clinical development of advanced therapeutic modalities, such as gene therapies and DNA vaccines. Additionally, pre-clinical plasmid DNA is suitable in preclinical safety and toxicology studies using large animal models. As this service utilizes the same platform manufacturing technology as VGXI’s cGMP Production Service, pre-clinical plasmid manufacturing ensures scalability to meet clinical demand as projects mature. Moreover, the pre-clinical product is a representative in quality to GMP grade as each plasmid is qualified using the same validated or USP test methods used in HD or GMP production. For clients needing additional support, we also offer cell line and process optimization services.
Trust our team to provide you with comprehensive manufacturing solutions that can streamline your research and development cycle and expedite progress in your therapeutic program.
Pre-Clinical Production Service Features
- 10L – 100L fermentation scale
- 1 to 15mg/mL plasmid DNA concentrations
- Fast turnaround time & delivery
- 100% of high-quality purified plasmid delivered
- Optional: cell line, process development and optimization services
Pre-Clinical Plasmid QC Release Testing
- Identity by agarose gel electrophoresis
- Purity by A260/280 ratio
- Nucleic Acid Concentration by A260 UV absorbance
- Structural Integrity (% supercoiled DNA) by HPLC
- Endotoxin by LAL assay
- % of residual host components (genomic DNA, RNA, and protein)
- pH
All final material is delivered with a Certificate of Analysis and is ready for use in your application.
