Pfanstiehl maintains an 8-acre, 135,000 sq. ft., 13-building campus in Waukegan, Illinois USA that provides all the manufacturing, laboratory, warehousing, and administrative operations — all designed to assure the smooth flow of materials and information and to allow production under cGMP.
Facilities
Dedicated and multi-purpose production facilities include:
- Potent drug manufacturing facility
- Class 100,000 drying facilities: isolated drying, milling, and packaging suites
- Lactate manufacturing: lactate salts and derivatives
- Pilot manufacturing: up to 300 gallon reactors
- Full scale (2,000 gallon), explosion-proof facility for processing with flammable solvents
- Fine chemical manufacturing
- Bulk cGMP manufacturing
- Research and development laboratories
- Solvent recovery facility
- Temperature and humidity controlled finished product warehouse
- Dedicated biological wastewater treatment facility
- 24-hour maintenance/engineering support staff
- analytical services lab
Capabilities
Our comprehensive custom services include:
- Kilogram to multi-metric ton production under cGMP conditions
- Process development, scale-up, optimization, and validation
- Potent drug manufacturing from 1 to 70 kg production lots
- Specialty carbohydrates and blocked sugars
- Extraction and isolation of specialty carbohydrates
- Purification, ultrafiltration, nanofiltration, electrodialysis
- cGMP documentation
- Analytical test method development and validation
- ICH compliant stability testing
- Drug Master File (DMF) development and maintenance
We work closely and confidentially with pharmaceutical and biotechnology companies that range from small and virtual to multi-national. We produce proprietary and public domain compounds per cGMP guidelines. From a single kilogram for clinical trials to multi-ton commercial quantities, you can trust Pfanstiehl to help you move your product quickly to market.