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Free standing, self contained, GMP approved manufacturing plant for relocation or operation in place – sale or lease.
Plant designed for 10 tpa bulk sterile, upgradable to 20 tpa. Previous product is the peptide BST – Bovine Somatotrophin.
Process Overview
- Fermentation plant
- Cell harvest plant
- Refold area
- Chromatography buffer make-up area
- Cool room
- Ultrafiltration and crystallization area
- Sterile areas including equipment prep and Edwards freeze drying
- Labs
- Tank Farm
Major Process Equipment
- 50m3 Fermentation system
- Alfa Laval centrifuge BTAX215S-31CEP-50
- Gaulin homogenizer
- Chromotography columns
- 50m2 Edwards Freeze dryer
- Schenk filter
- (2) Finn-Aqua clean steam generators, model 3000HP1
- (25+) reactors to 16,000 liter
- Tank Farm
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