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GMP Manufacturing

Upstream

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The highly segregated manufacturing facilities allow CMAB to handle multiple products in parallel. Single-use tanks are utilized in both media and buffer preparation to minimize risk of cross-contamination and allow rapid product change-over.


In the upstream area, four different products can be cultured simultaneously, one in each of the separate cell culture rooms


• Fully single-use technology
• Inoculation and expansion using Wave (GE and Sartorius) or 50L Bioreactor
• Cell culture capacities of 200L, 500L, 1000L, 2000L with GE and Sartorius Platforms
• Batch and fed-batch operation
• Harvest by depth filtration

1,500㎡ of classified cleanrooms segregated into upstream and downstream areas:


• Dedicated personnel locker rooms to bring all personnel into controlled-not-classified (CNC) conditions before entering production areas
• Upstream area comprising
• 5 x segregated inoculation rooms (Grade C)
• 4 x segregated cell culture rooms (Grade D)
• 2 x segregated harvest rooms (Grade D)

Supporting media preparation, media hold, washroom, In-Process Control (IPC), coldroom, and clean storage.

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