Cost-effective, faster alternative to full cGMP plasmid DNA

As your project matures from research to early phase clinical trials you will need higher quality plasmid or Nanoplasmid™ DNA. You will have to balance budget, timelines, and your risk tolerance to find the best quality grade for your needs. To help balance those needs, Aldevron pioneered GMP-Source™, a faster, cost-effective alternative to full cGMP manufacturing.

GMP-Source can be manufactured to standard or customizable specifications. Adopting the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation, GMP-S can be used as an ancillary or critical raw material for constructs used in clinical trials.

GMP-Source manufactured plasmid and Nanoplasmid DNA products offer:

• Screening for optimal growth conditions
• Growth via shake flask or high-density fermentation
• Alkaline lysis
• Chromatographic purification
• Consistent manufacturing process
• Certificate of Analysis (CoA)
• E. coli master cell bank generation
• Manufacturing summary report
• TSE/BSE statement
• Master Batch Records dictate process (controlled by Aldevron)
• ISO classified fill/finish with environmental monitoring
• QA oversight

Some clients choose GMP-Source to support pre-clinical and early phase trials. The data generated from a GMP-Source campaign can be utilized to assist the transition to full cGMP for later clinical trial phases. The GMP-Source process is so closely mapped to full cGMP that the transition is a smooth one.