Cambridge Major Laboratories announced a major expansion into large-scale active pharmaceutical ingredient (API) manufacturing. On June 5, the company says it will break ground on a new 120,000 square foot, API-manufacturing site next to its headquarters in Germantown, WI.
The facility is designed with multiple GMP manufacturing suites capable of producing multiton quantities of API. Completion is scheduled for August of 2009.
The facility will initially house six manufacturing suites with reactors up to 2,000-gallon scale with complete isolation and containment. In addition, it will house several vessels for hydrogenation and cryogenic reactions. The facility has been designed to accommodate additional manufacturing suites up to 4,000-gallon scale, and these will be built out as the needs arise.
Cambridge Major opened a new API development and small-volume manufacturing site in Germantown in 2004, and this facility is currently approaching the maximum of its operating capacity, according to company officials.