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.
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