API Development

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All of the capabilities required to provide API development and API manufacturing services

Alcami’s US 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 pre-clinical to post-NDA commercial production. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).

Alcami’s 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.

Alcami’s EU development center is located in Weert, Netherlands. The Weert facility is a 12,500 square meter site specializing in process research and development, scale-up, and manufacture of the API clinical supplies, supporting analytics, state-of-the-art Solid State Laboratory, and low volume commercial supply of API’s. The facility houses fully isolated pilot suites with reactors of up to 1000 liter, and is fully cGMP and ISO14001 certified and FDA inspected. The facility has a wide range of capabilities including plant scale cryogenics (-100C) and high temperature (260C), and high vacuum distillations.

Alcami’s Weert, Netherlands facility features:
  • 4  Process R&D Laboratories
  • 5  GMP Kilo Lab Suites
  • 3  Pilot plant suites (up to 1000 L)
  • Isolated Drying/Packaging Areas
  • 3  Analytical Laboratories
  • Solid State Laboratory
  • ICH Stability Chambers