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
