Highly Documented Plasmid DNA
Highly Documented (HD) Production Services: GMP-like Plasmid DNA for Clinical Applications
With twenty years of plasmid DNA production expertise and patented manufacturing technology, VGXI can deliver plasmid production services at different compliance levels for a full spectrum of applications ranging from research to commercial supply.
VGXI supports clients by offering two enhanced compliance options for plasmid DNA production: the HD and cGMP Plasmid Production Services. The HD Plasmid Production Service employs the same manufacturing technology as our cGMP Production Service, ensuring consistent and dependable quality throughout, while also offering a faster, more cost-effective alternative to cGMP production. The HD service yields plasmid preparations with high supercoil content and low endotoxin levels with additional quality testing and regulatory documentation. HD plasmids are ideally suited for use as a raw material for cGMP manufacturing of viral vectors, such as AAV, lentivirus, virus-like particles (VLPs) and other vectors, as well as for cell-based gene therapy applications and IND-enabling pharmacology and toxicology studies. For clients requiring additional support, we offer additional process development (PD) and final product aseptic fill/finish 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.
HD Plasmid Production Service Features
- 10L – 100L fermentation scale
- 1 to 15mg/mL plasmid DNA concentrations
- Up to 20g plasmid DNA delivered
- Suitable for plasmids up to 19kb
- Optional: PD and fill/finish services
HD 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
- Optional: Bioburden testing
The material is manufactured using a highly documented process, tested according to validated QC methods, and delivered with a HD Batch Record that has undergone rigorous QA document review, ensuring its readiness for use in your specific application.
