VGXI, Inc

VGXI MANUFACTURING PROCESS

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.