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December 22, 2003 Germantown, WI USA: Cambridge Major commenced groundbreaking of its new, state of the art, 50,000 square foot Process R&D and GMP Manufacturing facility in June 2003 near Milwaukee Wisconsin. Scheduled completion is July 2004. With over 20 reactors ranging from 25-500 gallon, the facility will have significant flexibility and will contain some specialty equipment to handle large scale cryogenics and hydrogenation. Housing 2 main reactor bays up to 500 gallon; 2 mini pilot plant suites up to 100 gallon, 5 GMP kilo lab suites, 4 process R&D labs, 2 analytical labs, spectroscopy suite, and 2 high potency suites (future build out), Cambridge Major will be one of the largest GMP development and small manufacturing facilities in the country.

Construction remains on track. The most recent milestone was the closing of the roof (December) allowing the installation of reactors and other equipment during the winter months. Starting early summer 2004, validation will commence.

Currently Cambridge Major operates an FDA inspected GMP facility housing 5 kilo labs and a pilot plant with reactors up to 100 gallon. This site will remain fully operational until validation of the new site is complete. Transfer of validated process will occur one-by-one until complete. Once in the new facility, Cambridge Major will vacate it current site which is currently for sale.

“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 API’s”, said Michael W. Major President and CEO of Cambridge Major. “Having the full process R&D and GMP manufacturing capability under one roof, we will be better positioned to address the needs of any Pharma or biotech customer from pre-clinical to post-NDA in a full GMP environment, eliminating the cost of tech transfers or revalidation of a project at a new site. We will continue to focus on niche (lower volume and orphan status) commercial API’s as our largest volume opportunities.”

“We chose Wisconsin to build the new facility because there is a very positive high tech business climate in the state,” said Dr. Major. “The Midwest in general seems to be shaping up as “The Third Coast” for growth and expansion of CRO/CMO’s with at least a dozen GMP custom synthesis players vying for high value projects against competition on the East and West Coasts. The low cost of living, quality educational institutions, good work ethic and drive to succeed are what make Wisconsin a great place to cultivate high tech businesses, not to mention state sponsored Industrial Revenue Bonds that provide an excellent vehicle for small and mid-sized high tech companies to grow their businesses.” Said Dr. Major.

Cambridge Major’s Director of Operations, John Zobel, said, “I have seen during my eight year tenure at CML that graduates from the University of Wisconsin system are well prepared to operate in a fast-paced and high pressure environment. The work ethic and devotion cannot be matched which is why we continue to grow, even in a down market.”

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