cGMP Plasmid DNA
Clinical and Commercial Plasmid Supply
With more than 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’s cGMP Production Service delivers the highest quality injectable-grade plasmid DNA in the industry. Since 2005, we have successfully manufactured over 310 batches — over 3 kilograms — of cGMP plasmid product for use in multiple applications, including human clinical trials, diagnostic reagents, and clinical through commercial supply of raw material for GMP viral vector and cell therapy production. Our highly skilled team can partner with you to design a customized manufacturing solution that aligns with your requirements. We also have a well-documented history of facilitating successful technology transfers for clients and providing process development (PD), optimization, and CMC support for single and multi-plasmid formulations as needed.
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.
cGMP Plasmid Production Service Features
- Up to 1500L fermentation scale
- Plasmid Evaluation
- GMP E. coli Master Cell Banking
- Scalable AIRMIX® Lysis Technology
- 1 to 15mg/mL plasmid DNA concentrations
- Optional: PD and GMP fill/finish services
cGMP Plasmid QC Full Panel 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
- Visual Appearance
- Bioburden (Microbial Enumeration Testing, MET)
All final material is delivered with a Certificate of Analysis and is ready for use in your application.
Our commitment to ensuring the highest quality cGMP plasmids involves rigorous QA/QC measures to meet established standards. Other hallmarks of our cGMP manufacturing include controlled raw material traceability and tracking, calibrated and validated equipment, and validated QC methods, to deliver reliable results. The entire production process undergoes formal QA document review, and each product is accompanied by a detailed batch record and certificate of analysis.
