API Development

Your Molecule. Our Motivation.

Alcami’s API development center is housed in a state-of-the-art 60,000 square foot cGMP facility. The site has all of the capabilities required to provide API development and API manufacturing services from early preclinical to post-NDA commercial production. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).

Germantown, Wisconsin Facility Features
  • 4 Process R&D Laboratories (glassware to 50L)
  • 5 GMP Kilo Lab Suites (glassware to 50L)
  • 4 GMP Plant Process Areas (26 reactors from 50 gal to 500 gal)
  • 3 Separate Analytical/QC Laboratories
  • 3 HEPA Filtered Drying Suites
  • 1 HEPA Filtered Packaging Suite
  • ICH Stability Chambers
  • GMP Storage/Warehousing Areas

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API Development

This facility incorporates all of the latest HVAC technologies for environmental and process control. The HVAC systems are controlled by a Building Automation System which constantly monitors the temperature, pressures and humidity of the processing areas (labs and plant). Each processing area contains its own Air Handling Unit with once-through air.

Download API Overview (PDF) Brochure