cGMP Manufacturing - Mammalian System

Certificates

2005
certificated by Taiwan FDA as a cGMP facility
2014
certificated by Taiwan FDA as a PIC/S GMP facility (till now)
2020
Granted approval by Japan PMDA
2023
Granted approval by US FDA

Mammalian Cell cGMP Production Facility

EirGenix has a strong track record in mammalian cell biopharmaceuticals, with extensive experience using CHO K1, CHO S, and HEK293 cells to develop and produce fusion proteins, monoclonal antibodies, bispecific/trispecific antibodies, and antibody-drug conjugates. Our state-of-the-art cGMP production facilities in New Taipei City (Xizhi) and Zhubei, Taiwan, support this work. The Xizhi facility (~10,000 sq ft) includes 100 L and 500 L stainless steel bioreactors and 50 L, 200 L, and 1,000 L single-use bioreactors (SUB), along with purification, medium and buffer preparation, washer, and autoclave rooms. The Zhubei facility, operational since 2019, houses two 1,000 L and four 2,000 L SUB systems, providing twelve 2,000 L SUB units and enabling annual antibody production of up to 1,000 kg.

Critical Equipment

  • 50L ~700L media and buffer preparation package
  • 100-500L stainless steel bioreactor trains
  • 50-200-1,000L-2,000L single use bioreactor trains
  • Millipore POD and 3M CUNO filtration system
  • 0.1~14 m2 Ultra Filtration concentration units
  • 3mm~10mm low pressure column chromatographic system with 5cm~60 cm columns.
  • central control system biopharmaceutical manufacturing facility