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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
Certificates
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