Facilities & Capabilities

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.

Kilo

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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.