Plasmid DNA
The WCBF has developed a process for the production of multi-gram quantities of clinical grade plasmid DNA utilizing scalable equipment and techniques that conforms to industry standards for sanitary design. In addition, no enzymes or organic solvents are utilized in the WCBF process and equipment that is utilized is typically available in large-scale versions to allow simplified process scale-up for future needs.
The WCBF plasmid production process is outlined below (click here for a text-only version of this chart)
Process Flow Diagram for production of plasmid DNA to vialed final product.
| Process | Typical Production Timeline |
| Master Cell Bank Production | 2 weeks |
| Master Cell Bank Testing | 2- 4 weeks |
| Fermentation | 1-2 weeks |
| Downstream Purification | 2-3 weeks |
| Aseptic Fill/Finish | 1 week |
| Release Testing | 4-6 weeks |
All stages are performed in classified cleanroom space with fermentation performed in the Microbial Products suite that consists of an ISO class 8 suite and downstream purification performed in a separate ISO class 7 suite.