Our Wisconsin facility provides full API development and manufacturing services to its customers working through all phases of the molecule lifecycle; providing capacity to support customers through to commercial manufacture.
With specialist high potency capability, as well as being fully certified for controlled substance handling, the team at our Wisconsin facility can provide a wide range of solutions.
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Fast Facts
Established in 1999
230+ employees
210,000 sq/ft facility
70+ molecules
Approved for schedule I to V controlled substances
Our Wisconsin facility delivers differentiated expertise across a variety of technical areas to support diverse development and manufacturing challenges and objectives.
Some of our key services include:
- Highly potent APIs (HPAPIs)
- Process development– Analytical development
- Synthetic route scouting
- Controlled substances (I-V)
- Technology transfer
- Solid state chemistry
- Spray drying
- Commercialisation and regulatory support
- Hydrogenation and cryogenic reactions at development and commercial scale
- Dry and wet milling
- Semi-prep and biotage chromatography
- Parallel synthesis
- M7 impurity assessment and control
Our Wisconsin site is home to an array of specialised facilities and equipment to overcome diverse challenges associated with API development, scale-up and manufacturing.
Some of the equipment and facilities we have on site at Wisconsin include:
- Three isolated kilo lab suites
- Two <30ng/m3 OEL containment, isolated cGMP suites, accommodating batch sizes up to 10 kg, as well as <1ng/m3 containment for batch sizes up to 500 g
- Cryogenic vessel for up to 2000L and -95°C
- Hydrogenation vessels for 15-350L/5-4000L
- MOC’s of GLS, SS and Hastelloy across all scales
- Broad range of API and intermediate vessel streams from 150-7500L
- Cone dryer, tray drying and agitated filter drying
- Static and dynamic humidification
- Lyophilisation
Our Wisconsin site offers cGMP manufacturing and controlled substance capabilities, with an impressive track record of successful inspections from the FDA, DEA, TFA and PMDA. We are also committed to protecting our planet, with specific goals in place to continually reduce energy, commuting and waste-related emissions.
