Zhubei Facility
The EirGenix Zhubei site operates two independent multi-product manufacturing building with flexible batch configurations and integrated upstream/downstream processing capabilities. EirGenix state-of-the-art cGMP facilities support both mammalian cell culture and microbial cell fermentation manufacturing in separated building across development and commercial stages. For mammalian production, EirGenix operates 200L–2,000L single-use bioreactors supported by integrated purification, media/buffer preparation, and final bulk filling and blast freezing. Microbial manufacturing capabilities range from 75L to 1,500L stainless steel fermentors, enabling flexible and scalable production for diverse biologic modalities.
Mammalian Cell Culture Manufacturing Facility
EirGenix’s mammalian manufacturing facility supports GMP manufacturing for monoclonal antibodies, bispecific antibodies, recombinant proteins, and other CHO cell-derived biologics. Designed with flexible single-use bioreactor platforms and scalable manufacturing capabilities, the facility supports programs from early-stage development through commercial manufacturing.
Capability Highlights
- Two independent multi-product mammalian manufacturing lines
- Single-use bioreactor platform from seed train to 2,000 L production scale
- N-1 perfusion-enabled upstream manufacturing
- Flexible batch configuration from 1x2,000L to 3 × 2,000 L
- Integrated downstream processing including chromatography, UF/DF, and viral filtration
- Modular downstream processing architecture with inline dilution capability and connected chromatography systems to support operational flexibility and efficient multi-product manufacturing
- Closed processing strategy with segregated GMP manufacturing suites
- Grade C and Grade D classified cleanroom operations
- Up to 50 lots/year per production line (~600 kg)
Microbial Cell Fermentation Manufacturing Facility
EirGenix’s Zhubei site microbial manufacturing facility supports GMP manufacturing for recombinant proteins, plasmid DNA, enzymes, vaccines, and other microbial-derived biologics.
Capability Highlights
- Dedicated microbial manufacturing facility with 75 L to 1,500 L fermentation platform.
- Support for recombinant E. coli., yeast, and Pichia expression systems
- Inclusion body and soluble protein manufacturing capabilities
- Integrated harvest, homogenization, and downstream purification infrastructure
- Support for refolding, pegylation, and conjugation processes
- Dedicated HVAC systems for function area with Grade C and Grade D cleanroom operations
- Up to 40 upstream lots/year and 80 downstream purification lots/year/each purification suite
