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 50L, 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

  • 20 L to 650 L media and buffer preparation package
  • 50 L, 200 L, and 1,000 L single use bioreactor trains
  • Depth filtration systems
  • 0.1~15 m2 Tangential Flow Filtration Systems
  • 6mm / 10mm low pressure column chromatographic system with 7cm ~ 45 cm columns
  • 100 L / 200 L / 650 L single use mixer with temperature control system
  • 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 to 200 L media and buffer preparation package
  • 20 L and 100 L fermentor unit
  • 100 L / 200 L / 400 L Single-Use Jacketed Mixing Units
  • Depth filtration systems
  • 10 L/hr and 100L/hr high pressure homogenizer unit
  • 10 L to 100L semi-continuous / batch centrifuge unit
  • 50 L / 100 L / 200 L /400 L single use mixer with temperature control system
  • 0.5~2.5 m2 Tangential Flow Filtration Systems
  • 3mm / 6mm low pressure column chromatographic system with 7cm ~ 45 cm columns
  • Bulk Filling Package
  • Temperature Control Unit
  • Clean-in-Place Unit