The company started work on the 50,000 square foot facility in June 2003 at a site near Milwaukee, Wisconsin. Once complete it will comprise more than 20 reactors (ranging from 25-500 gallons in capacity), specialty equipment to handle large scale cryogenics and hydrogenation and two main reactor bays (up to 500 gallons).

Also on the site will be two mini pilot plant suites, five GMP kilo lab suites, four process R&D labs, two analytical labs, a spectroscopy suite, and two high potency suites.

The new facility marks a significant hike in Cambridge Major's capacity. The firm currently operates a GMP facility housing five kilo labs and a pilot plant with reactors up to 100 gallons. This site will remain fully operational until validation of the new site is complete, but it will then close.

"The intent of the new facility is to add larger scale manufacturing to our traditional R&D and small scale GMP production of clinical and commercial APIs," commented Michael Major, the company's chief executive.

He added that having process R&D and GMP manufacturing capability under one roof will allow it to take projects from preclinical development through to the regulatory filing stage and beyond. This can eliminate the cost of technology transfers or revalidation of a project at a new site.

Cambridge Major focuses on niche (lower volume and orphan status) commercial APIs.