Facility overview: Wisconsin, US

At Sterling, our global facilities enable us to support our customers’ projects from grams to tons.

Welcome to our Germantown, Wisconsin, US site, which delivers full API development and manufacturing capabilities to support the lifecycle of each molecule.

Let’s take a closer look at five things you should know about our Germantown facility.

The Germantown site can support projects from development through to commercialisation. With comprehensive analytical and quality assurance services, an isolated kilo lab, world class pilot plant and API and intermediate vessel stream, supporting up to 7500 litres, the site is known for its specialised capabilities in high potency APIs.

By harnessing a multi-layer approach to containment and flexible equipment configurations, the team at Germantown can manufacture HPAPI batches up to 10kg.

The Germantown site also supports a broad range of complex chemistries, process design and product physiochemical characterisation capabilities, with robust capabilities in solid state chemistry, wet milling, chromatography, and parallel synthesis, as well as capacity for hydrogenation and cryogenic reactions up to 3500L.

The Germantown site is fully certified to handle schedule 1 through 5 controlled substances. The facility maintains stringent security controls and a strong working relationship with DEA to handle scheduled substances from process and analytical development through to full manufacture, import and export.

Finally the Germantown site is committed to remaining at the forefront of pharmaceutical innovation by investing in capabilities like spray drying, QSAR, impurity toxicity prediction, and toxin linker synthesis for antibody drug conjugates, the Germantown site continues to keep pace with industry changes and our customers objectives.

Sterling’s Germantown site delivers comprehensive solutions across the full API lifecycle backed by trusted partnership and extensive expertise.