The cGMP pilot plant has a 200 L bioreactor with the space to accommodate up to 1000 L bioreactor and all associated downstream processing for either secreted and intracellular products derived from recombinant yeast and bacteria.
The pilot plant has an Aseptic Suite equipped with a multi-purpose Class 10 isolator system that is sterilized with vaporized hydrogen peroxide and can be used for manual fills.
The support space houses raw material receiving, final product storage, and 5 validated stability chambers.
The cGMP utilities located in this space include:
- EDI water pretreatment system, a pure steam generator with a WFI condensor
- 1000 gal WFI storage tank
- WFI distribution system for both ambient and hot WFI
- Dedicated chilled water system that circulates 40 F water through the facility at 270 gpm
- Process and biowaste treatment system and an electrical system that is hooked up to a dedicated emergency generator
- Uninterruptible power supply
An $11.2 million Phase I/II cGMP pilot plant was completed on Dec 31, 2008. Designed and built by AES Clean Technology and BioKinetics, Inc, it has 6,000 square feet of cleanrooms and 7,000 square feet of support space. Commissioning and validation is underway.