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Delivering on the Promise of Purity

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.

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.