Xizhi Facility
The EirGenix Xizhi site facility supports GMP manufacturing for both mammalian cell culture and microbial fermentation programs, with dedicated manufacturing areas designed for clinical to commercial production. The facility also integrated with GMP cell banking suite.
The facility features flexible stainless steel re-use and single-use manufacturing platforms with integrated upstream and downstream processing capabilities to support diverse biologic modalities.
Mammalian Cell Production Line
EirGenix’s Xizhi mammalian manufacturing line supports 50L (wave system), 200L and 1,000L scale GMP manufacturing for monoclonal antibodies, recombinant proteins, and other mammalian cell-derived biologics. The Xizhi site includes a dedicated GMP cell banking suite supporting large-scale MCB and WCB production.
Capability Highlighs
- Automated cryovial filling and controlled-rate freezing systems for MCB/WCB Banking.
- Single-use bioreactor platform from 50 L to 1,000 L production scale
- Dedicated seed culture, cell culture, purification, and bulk filling suites
- Modular downstream processing architecture with inline dilution capability and connected chromatography systems to support operational flexibility and efficient multi-product manufacturing
- Integrated downstream processing including chromatography, TFF, nano-filtration, and viral filtration
- Bulk filling and blast freezing capabilities for GMP drug substance handling
Microbial Cell Production Line
EirGenix’s Xizhi microbial manufacturing site supports GMP manufacturing for recombinant proteins, enzymes, plasmid DNA, vaccines, and other microbial-derived biologics. The site also provides GMP microbial cell banking capability supporting MCB and WCB production.
Capability Highlighs
- Flexible microbial fermentation platform from 20 L to 100 L working volume
- Integrated upstream and downstream processing capabilities from fermentation through purification
- Both inclusion body processing and soluble protein processing platforms.
- High-pressure homogenization and integrated harvest infrastructure for microbial cell disruption processing
- Chromatography, TFF, and depth filtration purification capabilities
- Single-use mixing systems supporting flexible media and buffer preparation
- Bulk filling and blast freezing capabilities for GMP drug substance handling
- Automatic CIP-supported manufacturing operations
