Original construction completed in 1992 with continuous upgrades to support Phase III and commercial Launch (single product) operations. Approximately 23,000 SF of manufacturing areas including:

• Master Cell Bank (MCB)
• Cell Culture Expansion / Inoculation
• Sparging of Cell Culture Fluid
• Cell Culture Harvest Filtration
• Chemical Inactivation
• Ultrafiltration
• Buffer Formulation
• Downstream Processing

Design Features

• 6,000 SF BSL-3 Cell Culture Suite (CDC / NIH)
  • Batch culture process to 800 liters (4 x 200 liters)
  • 5 major processing areas with Biosafety Cabinets
  • 100 & 200 liter mobile culture tanks (>50 vessels)
  • Multiple automated LN2 cryostorage systems
  • Culture vessel sparging systems
  • 4 walk-in incubators
  • Cold storage (2-8 ºC) and decontamination autoclave
    

• 5,000 SF BSL-3 Downstream Processing Suite
  • 6 fixed inactivation process tanks (1,000 liters each)
  • UF / DF Systems (Pellicon & Prostak)
  • Chromatography room (K-Prime)
  • Multiple mobile process tanks
    (UF & Chromatography)
  • 2 fixed process buffer tanks
    (1,500 liters each)
  • Centrifugation room
  • Multiple Biosafety Cabinets
  • CIP system (WHE) for 8 fixed tanks
  • Steam Stations for mobile tanks
  • 3 tank Decon System and pass thru Decon
    Autoclave
    
    
    
• 3,100 SF Aseptic Processing Area
  • Aseptic Formulation / Filling of syringes
  • Multiple Class 100 areas
  • 2 HVAC Systems
  • BD Hypak container / closure system
  • INOVA Commercial system
    (IOQ complete)