Delivering on the Promise of Purity

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Delivering on the Promise of PurityTM

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Facilities & Capabilities

Pfanstiehl maintains an 10-acre, 180,000 sq. ft., 16-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.

Click here to see our Custom API or Carbohydrate Manufacturing Service options.

Active Pharmaceutical Ingredient Manufacturing

  • Potent API drug manufacturing facility scale:  1 to 70kg
  • Pilot manufacturing: up to 300 gallon reactors
  • Full scale (2,000 gallon), explosion-proof facility for processing with flammable solvents
  • Solvent recovery facility
API Kilo Lab Manufacturing Suite
  • Carlisle glove box synthesis isolator – Hastelloy C filter and contained tray drying
  • 100 liter glass reactor in Howorth full containment fume booth
  • 100 liter Hastelloy C hydrogenation reactor (50 psi)
  • Broad processing temperature range – (-)80ºC to (+)200ºC
  • Certified to handle compounds down to 0.10 ug/m³ – SafeBridge Category 4 capable
  • Kilo-scale non-cGMP custom synthesis
Pilot & Commercial Scale Manufacturing
  • Large Scale High Potency Manufacturing – Class 100,000 / SafeBridge Category 1-3 production facility
  • Multiple glass-lined 300 gallon reactor trains, with a total primary reactor capacity of 1,500 gallons
  • Flexible cGMP plant can produce up to ~100 Kg lots of potent / cytotoxic drugs
  • New 0.4 m² Hastelloy C Nutsche filter dryer with containment glove box isolator, as well as a multitude of portable Aurora filters (Hastelloy C and Stainless Steel)
  • Contained potent compound milling

Carbohydrate & Excipient Manufacturing

  • Bulk cGMP manufacturing scale:  Gram to Metric Ton
  • Class 100,000 drying facilities: isolated drying, milling, and packaging suites
  • Specialty carbohydrates and blocked sugars

R&D and Analytical

  • Research and development laboratories on-site
  • Analytical services lab:
    • Analytical method development and validation: 
      • Assay/release specification development for streamlined multi-compendial release
      • Impurity profiling
      • Structural analysis
      • Endotoxin and Glucan detection method development and validation
      • Elemental impurities quantitation at low ppb levels
      • Nitrosamine concentration, and N-Nitroso-structural impurities, nitrite concentration
      • DNA/RNA/DNase/RNase detection and validation
      • Reference standard qualification
      • Cleaning method development and validation
    • ICH stability testing and protocol development
    • Impurity marker characterization
    • KYPP Program to track and trend analytical quality attributes

Warehousing

  • Temperature and humidity controlled GMP finished product warehouse

Facility Support

  • Dedicated biological wastewater treatment facility
  • 24-hour maintenance/engineering support staff

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