Capable of processing at the 150L scale, this GMP facility was designed and engineered to accommodate intracellular and secreted protein.
The new cGMP facility can accommodate both recombinant bacteria and yeast expression systems at the 150 L-scale (working volume).
The facility is fully equipped with all the necessary downstream processing equipment to accommodate either an intracellular or secreted protein.
The new cGMP pilot plant has the following cGMP utilities; Meuller 7505 Pure Steam Generator with a Water For Injection (WFI) condenser, 1000 gal hot WFI storage tank, a Modular BioPharm ambient and hot WFI piping skid for recirculating both ambient and hot WFI throughout the pilot plant with drops in all processing suites, except for the Aseptic Suite.
The pilot plant also has dedicated process chilled water system that recirculates water at 40F throughout the facility, emergency back up generator, and a uninterruptible power supply (UPS) for all critical processing equipment.
The cGMP Pilot Plant is capable of making and testing cGMP buffers, which are moved through the facility using disposable bag technology.
The Aseptic Suite has a Class 10 Isolator System that is sterilized by Vaporized Hydrogen Peroxide (VHP) for doing manual fills up to 1,500 vials.
The aseptic processing suite houses a five-glove isolation chamber using vapor hydrogen peroxide (VHP) sterilization technology. The main isolator connects to mobile isolettes, permitting several simultaneous activities.
The facility was designed and built by AES CleanTechnology (clean rooms) and BioKinetics (process piping).