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cGMP Manufacturing - Mammalian System

EirGenix provides high-quality, cost-effective contract development and manufacturing services, supporting clients in development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial scale. We have a proven track record of inspections by regulatory authorities, including  EMA, TFDA, and others, and support commercial-scale production of successfully marketed products.

cGMP Manufacturing - Mammalian System

GMP Certifications and Inspections

2005
Certified by the Taiwan FDA as a cGMP facility.
2014
Certified by the Taiwan FDA as a PIC/S GMP facility.
2020
Successfully completed an inspection by Japan's PMDA.
2023
Successfully completed an inspection by the U.S. FDA.

Mammalian Cell cGMP Production Facility

EirGenix has a strong track record in cGMP manufacturing of mammalian cell-derived biologics, with extensive experience using CHO-K1, CHO-S, and HEK293 cells to develop and produce fusion proteins, monoclonal antibodies, bispecific and trispecific antibodies, and antibody-drug conjugates (ADCs). Our cGMP production facilities in Xizhi, New Taipei City, and Zhubei, Taiwan, support mammalian cell culture manufacturing from development through commercial production.

 

The Xizhi facility (approximately 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 (SUBs), along with purification, media and buffer preparation, washing, and autoclave rooms.

 

The Zhubei facility, operational since 2019, houses two 1,000 L and four 2,000 L SUB systems and supports 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