Microbial Products Suites
The Microbial Products suites are designed and equipped for producing plasmid DNA and other therapeutics from bacterial cells (e.g. recombinant proteins). The microbial products area is completely separate from the mammalian cell production areas, including a separate locker area and shower. In addition, the HVAC system that serves the microbial products area is completely separate from the air supply for the mammalian production areas.
The microbial products area includes a fermentation system and downstream processing equipment that is capable of producing 1–2 gram batches of clinical-quality plasmid DNA. Bulk plasmid DNA produced in this area will be dispensed into vials in the WCBF Aseptic Fill suite.
- Two suites, separate production and purification rooms, unidirectional flows
- Separate AHU providing air for ISO Class 8 (fermentation/recovery) and ISO Class 7 (downstream purification) suites
- Class II Type B3 biosafety cabinets (BSC)
- Steam-in-place fermentor with 30 liter working volume
- Scalable centrifugation system for product recovery
- Chilled tank and equipment for initial plasmid recovery or protein refolding
- Downstream purification equipment: preparative liquid chromatography (LC) system and scalable tangential flow filtration/diafiltration systems
- Dedicated buffer prep room