台康汐止廠
哺乳動物細胞廠
哺乳動物細胞表現系統GMP廠房位於於台康汐止廠的一樓，包含 50 L、200 L、1,000 L規模的cGMP生產，細胞庫之製備每批最多可提供約300細胞凍管之生產。生產之後，以先進技術提供純化、過濾和病毒清除等步驟，以滿足相關的品質要求。
相關儀器設備
- 20 L to 650 L media and buffer preparation package
- 50 L, 200 L, and 1,000 L single use bioreactor trains
- Depth filtration systems
- 0.1~15 m2 Tangential Flow Filtration Systems
- 6mm / 10mm low pressure column chromatographic system with 7cm ~ 45 cm columns
- 100 L / 200 L / 650 L single use mixer with temperature control system
- Nano-Filtration Unit
- Bulk Filling Package
- Temperature Control Unit
- Clean-in-Place Unit
- cGMP Biopharmaceutical Manufacturing Facility Central Control System
微生物廠
微生物表現系統之GMP生產廠房位於台康汐止廠的5樓，由接種室、發酵收穫室、純化室、分裝室、緩衝液配置室、洗滌暨高壓滅菌室。對於微生物表現系統之生產，台康可提供30L和150L（培養體積20L和100L）的發酵產能。細胞庫每批最多約可提供300個小瓶
相關儀器設備
- 20 L to 200 L media and buffer preparation package
- 20 L and 100 L fermentor unit
- 100 L / 200 L / 400 L Single-Use Jacketed Mixing Units
- Depth filtration systems
- 10 L/hr and 100L/hr high pressure homogenizer unit
- 10 L to 100L semi-continuous / batch centrifuge unit
- 50 L / 100 L / 200 L /400 L single use mixer with temperature control system
- 0.5~2.5 m2 Tangential Flow Filtration Systems
- 3mm / 6mm low pressure column chromatographic system with 7cm ~ 45 cm columns
- Bulk Filling Package
- Temperature Control Unit
- Clean-in-Place Unit
