All of the Capabilities Required to Provide API Development and Manufacturing Services.
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).
Our 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
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.