cGMP Manufacturing - Mammalian System
Review how a comprehensive cGMP manufacturing facility is poised to support the development and manufacture of your mammalian cell program.
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 officially operated in 2019. Two 1,000L and four 2,000L Single Use Bioreactor (SUB) system in the new facility; there are building the other parts for total twelve 2,000L Single Use Bioreactor (SUB) and annual capacity of monoclonal antibody will be 1,000kg.
Critical Equipment
- 50L ~700L media and buffer preparation package
- 100-500L stainless steel bioreactor trains
- 50-200-1,000L-2,000L 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, and HEK293. Our team has supported our clients in the development and manufacture of fusion proteins, monoclonal antibodies, bi-/tri-specific antibodies and antibody drug conjugate products.
Certificates
- 2005 certificated by Taiwan FDA as a cGMP facility
- 2014 certificated by Taiwan FDA as a PIC/S GMP facility (till now)
- 2020 Granted approval by Japan PMDA
- 2023 Granted approval by US FDA