EirGenix is an organization that provides contract development and manufacturing to perform high quality and cost-effective services supporting our clients in development, analytical testing, and GMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing.

Mammalian Cell cGMP Production Facility

Our state of the art mammalian cell cGMP production facility is located in the first floor of our building with footage around 10,000 square ft. It consists of two bioreactor trains, i.e., 100/500L stainless steel bioreactors and 50/200/1,000L single use bioreactors, in two independent production suites; one purification room, one final purification room, one medium preparation room, one buffer preparation room, a washer room and a autoclave room. A new commercial facility located in northern part of Taiwan is currently under construction. Two 2x2,000L Single Use Bioreactor (SUB) system in the new facility will be on line for service in 2018.

Track Records

EirGenix has multiple project experience using different cell lines including CHO K1, CHO S, NS0, and PER.C6. Our team has supported our clients in fusion protein and monoclonal antibody development.

Certificates

The Taiwan FDA certified our mammalian cGMP facility in 2005.The most recent follow-up inspection approval was in Oct. 2015. This facility is also registrated with the US FDA since 2006. The DMF type five registration number is 19164.

Certificates