Commercial Manufacturing Service: Mammalian
KBI's strategic commercial manufacturing expansion project is currently in progress with the aim of being commercial manufacturing ready by 4Q 2017.
Building on KBI’s legacy of being the first CMO in the world to implement the 2000L scale Xcellerex™ single-use bioreactor, the first stage of this commercial expansion effort will result in a commercial manufacturing suite equipped with an initial set of 2X 2000L Xcellerex™ bioreactors and a dedicated purification suite (3 purification rooms).
This commercial manufacturing suite and related equipment will be highly flexible by taking advantage single-use technologies for each unit operation leveraging our extensive experience with large scale single-use equipment.
It will also be operated with strict adherence to regulations required for cGMP biopharmaceutical drug substance manufacturing.
The following additional capabilities will be added as part of this expansion effort in support of this new commercial manufacturing suite:
- In-house media and buffer preparation facility
- WFI generation
- Expansion of clean unclassified areas
- Material storage (cold and ambient)
- Additional warehouse capacity
Facility expansion, required equipment commissioning and qualification activities are scheduled to complete by Q4 2017.
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