HIGH-POTENCY API DEVELOPMENT & MANUFACTURING

Turning Today's Concepts into Tomorrow's Medicines.™

The increasing trend of highly potent active pharmaceutical ingredients (HPAPI) being used in new drug development candidates has created a tremendous demand for high containment development and production capabilities. 

To meet this industry need, Alcami has invested significantly in the enhancement of its US API manufacturing and development campus in Germantown, Wisconsin with expanded state-of-the-art HPAPI development and manufacturing facilities.

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State-of-the-Art Features and Support
  • Primary containment and engineering controls for nanogram-level containment
  • Dedicated utility and support systems for superior reliance and control 
  • Expert support in areas of quality and hazard risk assessment along with mitigation
  • Full development and QC support
Multiple Levels of Containment
  • Versatile Howorth™ Air Technology downflow booths
  • Fully enclosed process equipment 
  • Isolator and ChargePoint® technologies 
  • Isolated HEPA filtration airflow 
  • Interlocked personnel and materials flow airlocks
Process Capabilities
  • Small molecule chemistry from gram to 10kg batch size 
  • Glass and Hastelloy® C-22 PLC-controlled reactors up to 100L 
  • Distillation, cryogenic, and hydrogenation capabilities
  • Aurora® filter isolation, drying, and packaging
  • Versatile enclosed processing space for expanded portable capabilities

HPAPI

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Download API Overview (PDF) Brochure