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Upstream Process

̳ؽ cGMP EU-GMP ؿ յǵ ̻ ȿ ý۰ ý ܹ Ǿǰ 񽺸 ϰ , پ ü Ǿ ֽϴ. Upstream ׵ и, ȸ, Ϸ ܰ Ѿ Ǹ, ڵȭ ǰ ȿ شȭ߽ϴ.

- Cell Banking(MCB & WCB )
- ̻ ȿ: Batch, Fed-batch mode
- : Batch, Fed-batch, Perfusion culture mode
- Scale-up ȭ
- cGMP SOP & Process Validation

Fermenter Sartorius-BBI Systems, Germany

̳ ȿ յ ϴ ȿ а µ, , pH ֵ ֹ 25 L working volume ȿ 500 L working volume ȿ ũ ̷ ֽϴ.
ڵȭ Ʈ ý batch Ÿ̳ fed-batch Ÿ ȿ Ͽ, ӻ ÷ ұԸ մϴ.

Bioreactor Sartorius-BBI Systems, Germany

Ƿ ü ܹ Ǿǰ ϴ ϴ μ 50 L working volume Bioreactor 500 L working volume Bioreactor ̷ Batch, Fed-batch mode Ǵ Spinfillter ̿ Perfusion mode Fully-automated system ߰ ֽϴ.
ʹ W.V. 500 L Wave Bioreactor Train ߰ ֽϴ.

CIP System Sartorius-BBI Systems, Germany

ǰ꿡 ̵̳ ü ô ̷, ڵȭ ý ߰ ־ ִ ô մϴ.

Centrifuge (ɺи) Alfa Laval, Sweden

cGMP EU-GMP ؿ µ Ͽ ֹ Ͽ, ڵȭ CIP SIP ߰ ־ ü и ߻ϴ Ҽ ȿ ֽϴ.

Homogenizer (ļ) Microfluidics, U.S.A

ü 빰 иϱ з ̿Ͽ ü ļϴµ Ǵ ļ cGMP EU-GMP ؿ µ Ͽ ֹ Ͽ, ڵȭ CIP SIP ߰ ֽϴ.

Downstream Process ()

̳ؽ پ ̿Ǿǰ 꿡 ȭ Ȯϰ , ̿Ǿǰ Ǿǰ 꼭񽺸 մϴ.

- Pilot scale commercial scale پ Ȯ
- Dedicated HEPA System Ƿ µ (~) Environmental room 
- Virus inactivation/ filtration Pre- and post-virus removal 
- Cross contamination ϴ Disposable concept Bag system

- Chromatography skid (GEHC, Millipore)

- Chromatography column (GEHC, Millipore)

- Ultrafiltration / Diafiltration skid (Pall)

- Virus filtration skid (Millipore)

- Buffer preparation Tank (Sartorius)

- Disposable mixer (Xcellerex, Pall, Millipore)