Complete 14,000 m2 (140,000 ft2), free standing, self contained, GMP approved protein manufacturing center located in Europe. Built up area includes production area, offices and conference rooms, development and QA/QC laboratories, warehousing, support plant, and tank farm.
Plant present capacity is 10 TPA bulk sterile injectable, but is designed with a provision for future upgrade to 20 TPA.
Plant built in 1987 at an original investment of $68 million USD and upgraded in 1995.
- 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 Lypholization
Major Process Equipment:
- 50m3 Fermentation system
- Alfa Laval centrifuge BTAX215S-31CEP-50
- Gaulin homogenizer
- Chromatography columns, 2m DEAE and 1.4m G25
- 1000 liter (50m2) Edwards Freeze dryer - Sanitary
- 30 m2 Schenk filter
- (2) Finn-Aqua clean steam generators, model 3000HP1
- (25+) reactors to 16,000 liter
- Labs
- Stainless steel Tank Farm
