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