Dedicated to Quality Every Step of the Way
A typical plasmid DNA manufacturing run can vary from 4 to 8 months depending on the unique requirement of the client’s project. Standard steps of the VGXI process are described below.
Plasmid Evaluation
Each new plasmid is first evaluated by the Process Development team in a small scale production run called a Plasmid Evaluation. This pre-clinical production run simulates conditions of the full-scale GMP run to assess the quality and yield of the Customer’s plasmid.
Cell Banking
If included in the project scope, generation of a GMP Master Cell Bank is performed in a dedicated area starting from the fully evaluated research cell bank.
Fermentation
Each plasmid is unique, and VGXI has the knowledge and experience to optimize fermentation based upon the project’s specific requirements. Advantages of VGXI Fermentation include:
- Fully automated process
- E. coli fermentation scales up to 500L
- Capability and experience with both batch and fed batch methods
- Experience with both antibiotic and antibiotic free selection
The fermentation process occurs under strictly controlled growth parameters and is carefully monitored from the moment the bacteria enter the fermentor to the point of harvest.
Lysis
When scaling plasmid production, lysis and neutralization is a highly critical step. VGXI’s patented AIRMIX® Technology gently separates the DNA plasmid from cellular debris in an efficient, reliable manner. Characteristics of the AIRMIX, superior approach:
- Fully automated and scalable process
- Continuous capture method effectively lyses cells at a high rate without damaging cellular contents
- Low shear minimizes genomic DNA contamination and preserves DNA supercoiling
- No animal-derived components
Purification
Optimized downstream chromatography steps further remove impurities including host cell genomic DNA, RNA, proteins, and endotoxin.
Concentration and Aseptic Filtration
Final concentration and buffer exchange is achieved with tangential flow ultrafiltration/diafiltration (UF/DF).
- Controlled transmembrane pressures preserve plasmid DNA integrity
- Experience in producing plasmid concentrations up to 15 mg/mL
- Formulation available with a wide range of buffers and excipients
Contact us today to learn more about how the VGXI process can ensure the success of your clinical program.
