Xizhi Facility

Mammalian Cell Facility


The mammalian cGMP production facility is located on the 1st floor of our Xizhi facility and occupies just under 4,000 square feet of operational space. For mammalian cell production, our facility provides 200 L and 1000 L-scale cGMP manufacturing using single-use bioreactor trains. Our GMP Cell Banking area can provide maximum 300 vials per batch. We apply established advanced technologies to accommodate all relevant methods and scales of chromatography, resin, filtration, and viral clearance, to meet all quality requirements.

Critical Equipment

  • 50 to 650 L Media and Buffer Preparation Package
  • 200 L / 1000 L Single-Use Bioreactor Units
  • 50 L / 100 L Portable Tank Reactor Units
  • 200 L / 650 L Single-Use Mixing Units
  • 200 L /650 L Single-Use Jacketed Mixing Units
  • Millipore POD and 3M CUNO Filtration System
  • 0.1 to 6 m2 Tangential Flow Filtration Units
  • 6 mm / 10 mm Low-Pressure Column Chromatographic System with 5 to 60 cm Columns
  • Nano-Filtration Unit
  • Bulk Filling Package
  • Temperature Control Unit
  • Clean-in-Place Unit
  • cGMP Biopharmaceutical Manufacturing Facility Central Control System

 

 

Microbial Facility

The microbial cGMP production facility is located on the 5th floor of our Xizhi facility with a total area of around 4,000 square feet. It consists of inoculation suites, fermentation & harvest suites, purification suites, bulk fill room, buffer preparation room, and wash & autoclave room. For microbial cell production, our facility can provide a fermentation capacity of 20 L and 100 L (by working volume) units. The GMP Cell Banking area is independent from the main facility area, and it can provide a maximum of 300 vials per batch.
 
 

Critical Equipment

  • 20 L / 100L Fermentor Unit
  • 100 L / 200 L / 400 L Single-Use Jacketed Mixing Units
  • Millipore POD and 3M CUNO Filtration System
  • Semi-Continuous Floor Centrifuge Units
  • High-Speed Homogenizer Units
  • 10 L/HR - 120L/HR High-Pressure Homogenizer Units
  • 0.1 to 6 m2 Tangential Flow Filtration Units
  • 6 mm Low-Pressure Column Chromatographic System with 5 to 45 cm Columns
  • Bulk Filling Package
  • Temperature Control Unit
  • Clean-in-Place Unit