Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical Intermediates and Active Pharmaceutical Ingredients, in gram to multi-ton commercial quantities. We serve such markets as pharmaceutical, biotechnology, veterinary and cosmetics. With over 50 years experience in custom synthesis and process development under cGMP guidelines, we are uniquely qualified to move new compounds from the laboratory to the commercial marketplace.
Our custom services include:
- Custom synthesis of Active Pharmaceutical Ingredients and advanced intermediates
- Process development/scale-up
- Process validation
- Stability testing
- Test method development and validation
- Clinical Trial Material (CTM) and supporting documentation
- Drug Master File (DMF) development and maintenance
Working closely with clients ranging from virtual pharmaceutical companies to the world’s largest multinational pharmaceutical and biopharmaceutical producers, we synthesize proprietary and commercial compounds in quantities ranging from grams to tons. Manufacturing and development take place within a 13-building campus located near Chicago, Illinois.
Our key product technologies:
- High Potency Substance manufacturing in a certified development and commercial scale multi-purpose containment chemistry manufacturing facility
- High-purity, low-endotoxin carbohydrates
- Blocked sugars and derivatives
- Modified carbohydrates, polysaccharides and oligosaccharides
- Custom di-and tri-saccharides / complex carbohydrates
- Sugar acids, esters, alcohols, lactones and salts
- Injectable Grade Lactate salt solutions
In everything we do, Pfanstiehl is motivated by a concern for both product quality and environmental/worker safety. We design and equip our plant, write our procedures and train our people to meet or exceed US FDA, cGMP, OSHA and international regulatory and multi-compendial standards.