Zhubei Facility

Mammalian Cell Facility

The upstream suite at our Zhubei facility provides seed sizes from as small as 1 vial, up to 50 L, 200 L and 1,000 L single-use bioreactors (SUBs), which are then transferred to our 2000 L main cell culture single-use bioreactors. The downstream suite is equipped with a diverse range of chromatography skids and columns of varying sizes, including nanofiltration and ultrafiltration units capable of handling between 2 to 16 kg of harvested cell culture. Several methods are implemented to ensure a closed operation and minimize any cross-contamination of batches. Single-use mixing bags during pH/conductivity adjustments and holding of intermediate products, while sterile tube welders and aseptic connectors are used extensively in connections. All productions activities from seed culture, main cell culture, initial purification and final purification (post-viral) are processed in separate rooms with their own dedicated HVAC systems. The seed culture and final purification rooms are cleanroom controlled under a Grade C-level, with all other production areas controlled at a Grade D-level.
 

Mass Production Capacity

 Production LineMax. Production Capacity*

STAGE 1 

Mammalian Cell Facillity

(Production Line 1)

200 L Single Use Bioreactor x 1

1,000 L Single Use Bioreactor x 2 

2,000 L Single Use Bioreactor x 6

Downstream Process Equipment x 1

Max. Production Capacity of Antibody

45 Lots/Year (180,000 L/Year)

~480 Kg mAb/Year

STAGE 2 (by mid-2023)

Mammalian Cell Facility

(Production Line 2)

200 L Single Use Bioreactor x 1

1,000 L Single Use Bioreactor x 2 

2,000 L Single Use Bioreactor x 6

Downstream Process Equipment x 1

Max. Production Capacity of Antibody

45 Lots/Year (180,000 L/Year)

~540 Kg mAb/Year

STAGE 3 (~2022-2023)

Microbial Facility - Production Line

1,000 L Fermentor x 1

Downstream Process Equipment x 2~3

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Critical Equipment

  • 50 L / 200 L / 500 L / 1,000 L Single-Use Mixer Media Preparation Package
  • 50 L / 200 L / 500 L / 1,000 L Single-Use Mixer Buffer Preparation Package
  • 50 L / 200 L / 1,000 L Single-Use Bioreactors, Seed Train to 2 x 2,000 L Single-Use Bioreactors
  • 6 x 2,000 L Single-Use Bioreactors (Main Cell Culture) 
  • One Intermittent-Discharge Disc-Type Continuous Centrifuge and CIPs (~2 T/HR)
  • Up to 20 m2 3M CUNO Depth Filtration Skids
  • Two 2-Pump and One 3-Pump 1-Inch Chromatography Skids
  • Two 600/300 mm and Two 800/300 mm AxiChrom Columns
  • Up to 15 m2 Automated Ultrafiltration Skid
  • 200 L to 2,500 L Jacketed Single-Use Mixers with Load Cell and TCUs
  • Final Bulk Filling package in Laminar Flow Cabinet
  • Two Blast Freezers for Handling Stedium FFT Storage Bags
  • Ample Storage Space in 2-8 C and -40 C Cold Rooms