Certificates

2013 certificated by Taiwan FDA as a cGMP facility

2014 certificated by Taiwan FDA as a PIC/S GMP facility (till now)

2020 Grant approval by Japan PMDA (till now)

Microbial cGMP Production Facility

EirGenix operates microbial cGMP production facilities in Xizhi and Zhubei, Taiwan, with extensive project experience using E. coli and Pichia expression systems. The Xizhi facility supports fermentation, purification, bulk filling, and cell banking, with fermentation capacities from 20 L to 1,000 L and ongoing commercial production. The Zhubei facility, operational since 2026, enables scale-up from pilot to late-stage clinical and commercial manufacturing (30–1,000 L) using automated, closed systems and industrial-grade purification equipment.