EirGenix is established on a dual business model; (1) internal product development of biologics, specifically biosimiliar and biobetter development, and (2) a biologics-based contract development and manufacturing organization (CDMO). In regards to the CDMO business, EirGenix provides full-scope services from cell line development and process optimization, to small-scale and commercial GMP manufacturing of both mammalian and microbial cell-based biologics. EirGenix has PIC/S GMP-compliant facilities that are operated with the highest efficiency, ensuring the company delivers both high-quality and cost-effective products to our clients. As of now, EirGenix has accomplished more than 60 CDMO projects that include the development of various biologics such as mAbs, bispecific mAbs, fusion proteins, recombinant proteins, protein vaccines, and plasmid DNAs. EirGenix has built a state-of-the-art PIC/S GMP commercial manufacturing facility in Zhubei Biomedical Science Park. Until now, EirGenix has successfully completed multiple 2,000L/4,000L GMP and PPQ runs. Currently, four 2,000L SUBs are fully operational and an additional eight 2,000L SUBs will be installed for future expansion in the coming years. With a total capacity of 24,000L, EirGenix aims to expand further into the Asian, European, and North American markets.
更多資料