This week marks the dedication of a large-scale active pharmaceutical ingredient manufacturing facility in Germantown, WI, by contract manufacturer Cambridge Major Laboratories. The company intends the facility, comprising six GMP suites capable of producing multi-ton quantities of APIs and advanced pharmaceutical intermediates, to be a high-quality, US-based supply option. Its construction became necessary as the company outstripped capacity at three sites--two in Germantown and another in the Netherlands, for an overall capacity of 400 manufacturing projects per year.
According to Brian Scanlon, chief business officer, Cambridge Major "wanted a homegrown facility, nearby for our control over it and for supply chain purposes, with no questions about quality. We didn't consider an offshore location."
The company plans to produce small molecule and general chemical substances--a combination of newly launched commercial APIs and some clinical APIs--in hopes of retaining the clinical business should those substances advance through the NDA stage. Current plans involve no highly toxic or cytotoxic substances.
Installed capacity totals 18,000 gallons (70 cubic meters), with expansion capability of 30,000 gallons (120 cubic meters). Thermal oxidizer technology aids in compliance with air quality standards. A large-volume tank farm yields efficiency in the use of solvents, according to the company.
FDA inspection of the facility is planned for the first half of 2009; the Germantown campus is already FDA-approved, Scanlon says.
- here's the announcement