cGMP manufacturing–mammalian system

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.

Critical Equipment

  • 50L ~700L media and buffer preparation package
  • 100-500L stainless steel bioreactor trains
  • 50-200-1,000L single use bioreactor trains
  • Millipore POD and 3M CUNO filtration system
  • 0.1~14 m2 Ultra Filtration concentration units
  • 3mm~10mm low pressure column chromatographic system with 5cm~60 cm columns.
  • central control system biopharmaceutical manufacturing facility 

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.

Prior monoclonal antibody project experience

  • Anti-IL 20 (CHO, PER.C6)
  • Anti-HSV (CHO)
  • Anti-TNFα(CHO)
  • Biosimilars (CHO)

Production of antibody for US clinical trial

Production of antibody for EU clinical trial

Production of antibody for Taiwan clinical trial

Production of antibody and Fc-fusion protein for GLP tox study

Certificates

Year

Certificate and Inspection

2005

certificated by Taiwan FDA as a cGMP facility

2014

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

2017

received accreditation certificate of foreign manufacturer from Japan