Sterling Germantown, WI, US facility houses a state-of-the-art cGMP development, scale up and manufacturing capabilities. The site has all the requirements to provide API clinical and commercial manufacturing services, including high-potency API manufacturing. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics.

Germantown API facility USA

Development

Our team of more than 27 skilled scientists provide comprehensive capabilities including:

  • Knowledge in synthetic route scouting
  • Expertise in technology transfer, process development and industrialisation
  • Solid State Chemistry team to support solid form development
  • Full range of supporting analytical services including LCMS, XRPD, ICPMS and NMR
  • Validation support services (DoE, QbD)
  • Process hazard evaluation services
  • Controlled substance process and analytical development

Manufacturing

Kilo labs, Pilot plant and HPAPI:

  • Controlled substance manufacturing
  • Kilo Lab Suites:
    • 3 x Isolated Suites
    • Up to 50L Portable Reactors
    • Buchi Rotavapor
  • Pilot plant:
    • Multiple trains from 150 – 1500 L vessel scales
    • Cryogenic Vessel – 250 L vessel
    • Hydrogenation Vessels – 15-350 L vessels
    • Separation Equipment – 2 x 600 mm Vertical Basket Centrifuges
    • A range of isolation equipment including filters and dryers
  • HPAPI:
    • up to 10kg batch size
    • Glass/Hastelloy fully functional reactors up to 100L (low minimum agitation design)
    • Additional small-scale equipment available
    • Cryogenic capabilities
    • Heated and cold filtration / isolation
    • Fully contained drying and packaging
    • Hydrogenation to ~90psi

Large scale:

  • Broad range of API and intermediate vessel streams:
    • 1500 – 7500 L
  • Cryogenic Suite:
    • 1500 – 3500 L
  • Hydrogenation Suite:
    • 1500 – 3500 L
  • Separation Equipment:
    • 2 x 800 mm Krauss-Maffei Horizontal Peeler Centrifuges
    • Multi-sized Portable Nutsche Filters (SS)
  • Drying Equipment:
    • Cone dryer
    • Tray drying
  • Solvent Tank Farm

Sterling Germantown, WI Facility

W132 N 10550 Grant Drive
Germantown,
WI 53022
USA

Germantown, WI telephone:
+1 262 251 5044