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cGMP Production Service
cGMP Quality Plasmid DNA Manufacturing for Clinical Through Commercial Supply
VGXI's cGMP Production Service gives you injectable-grade plasmids suitable for human clinical trials and commercial supply. Our patented AIRMIX® manufacturing technology produces the highest quality plasmids in the industry with supercoil percentages >99% and final product concentrations up to 15mg/ml. Our highly experienced team is ready to work with your project’s unique requirements to create a manufacturing solution that ensures your success.
Contact us today for a quotation!
Applications
- Diagnostic reagents
- Human clinical trials
- Commercial supply
Capabilities
- 100-500L fermentation
- Cell banking
- Process development
- Toxicology production
- Bulk production
- Fill/finish
- Stability testing
Additional Services
- Accelerated stability
- CMC preparations
- Auditing services
- Assay development
- Formulation development
Key Advantages
- Ownership and control of in-house manufacturing capability from master cell bank (MCB) to final drug product
- Flexible, purpose-built facility used for research, development, and clinical supply
- Key personnel with expertise allowing for rapid development of products
- Quality Systems in place to meet regulatory requirements
- A cost-effective process that has been scaled to meet clinical and commercial needs
- Process easily transferable to alternate locations if required
- A track record of success in meeting goals and supplying clinical studies