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200L、1000L規模的cGMP生產,細胞庫之製備每批最多可提供 約300個小瓶。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
- 50 to 650 L Media and Buffer Preparation Package
- 200 L / 1000 L Single-Use Bioreactor Units
- 50 L / 100 L Portable Tank Reactor Units
- 200 L / 650 L Single-Use Mixing Units
- 200 L /650 L Single-Use Jacketed Mixing Units
- Millipore POD and 3M CUNO Filtration System
- 0.1 to 6 m2 Tangential Flow Filtration Units
- 6 mm / 10 mm Low-Pressure Column Chromatographic System with 5 to 60 cm Columns
- 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 / 100L Fermentor Unit
- 100 L / 200 L / 400 L Single-Use Jacketed Mixing Units
- Millipore POD and 3M CUNO Filtration System
- Semi-Continuous Floor Centrifuge Units
- High-Speed Homogenizer Units
- 10 L/HR - 120L/HR High-Pressure Homogenizer Units
- 0.1 to 6 m2 Tangential Flow Filtration Units
- 6 mm Low-Pressure Column Chromatographic System with 5 to 45 cm Columns
- Bulk Filling Package
- Temperature Control Unit
- Clean-in-Place Unit