Multi Process and Product Facility

• Recombinant Bacterial Production
• Recombinant Fungal Production
• Insect Cell Culture / Baculovirus Expression System (BEVS)
• Chemical Synthesis / Protein Remodeling / Solvent Processing

Design Features

• Microbial Fermentation Suite (Class 100,000)
  • 20L – 200L – 2,000L fermentation train
  • 2,000L harvest and hold vessels
  • Associated continuous centrifuges and homogenizer
  • Dedicated Class 10,000 purification suite
• Fungal Fermentation / Cell Culture Suite (Class 100,000)
  • 20L – 200L – 2,000L fermentation / cell culture train
  • 2,000L harvest vessel
  • Associated continuous centrifuge
  • Dedicated Class 10,000 purification suite
• Insect cell/BEVS Production Suite (Class 100,000)
  • 20L – 200L Disposable Bioreactor (Wave) systems
  • 100% Outside Air for organism containment
• General Purpose Chemical Processing Suite (Class 100,000)
  • 100L – 4,000L processing vessels
  • Seven Chromatography Skids at various scales
  • Pilot scale TFF, Diafiltration, and RO skids
  • Two Class 10,000 rooms for purification
• Chemical / Solvent Processing Room, Class I/Div. 2 (Class 100,000)
• Central Media/Buffer Preparation Rooms
• Central Process Network / Automation System
• Central Cleaning Corridor
  • Large parts washer
  • Pass-through Autoclave
  • Portable tank CIP and SIP stations
• Central CIP System and mobile CIP capabilities
• Cold Storage Capabilities
  • Large, walk-in cold storage rooms (2 – 8 C)
  • Large, walk-in freezer (-20 C)
  • Central cryostorage system
• Critical Utilities
  • USP Purified Water
  • Clean Steam
  • Compressed Air
  • HVAC
• Process Waste Neutralization
• Emergency / Back-up Generator

Validation and Equipment Status

• Facility Environmental Baseline Established
  • HVAC qualified through IOQ
  • Routine monitoring on-going
• Critical Utilities qualified through PQ
  • Routine monitoring on-going
• Process equipment qualified through IOQ
  • Sterilization of equipment qualified through PQ (where applicable)
• Central Process Network / Automation system qualified through IOQ, 21CFR11 compliant
• Validation protocols maintained on-site
• Equipment manuals and maintenance history records maintained on-site
• Calibration records maintained on-site