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Cambridge Major Announces Dedication of New cGMP Facility

Company Advances Goal to be Top Contract Research and Manufacturing Organization in the Country

 

June 11, 2004 Germantown, WI USA: Cambridge Major Laboratories, Inc., today announced the Dedication of it’s new cGMP facility to take place on June 24, 2004. The opening of the facility marks completion of the one year construction project. The 10 acre campus is located in a new industrial park approximately 5 miles from Cambridge Major’s existing Germantown site. With 16 reactors ranging from 50-500 gallon, the facility will have significant flexibility and will contain some specialty equipment including large scale cryogenics and hydrogenation. Housing 2 main reactor bays up to 500 gallon; 2 mini-plant suites up to 100 gallon, 5 GMP kilo lab suites, 4 process R&D labs, 2 analytical labs, a spectroscopy suite, and 4 isolated drying suites, Cambridge Major will be one of the largest cGMP contract development and small manufacturing facilities in the country.

The project has been financed through a Wisconsin Industrial Revenue Bond issuance and the Company’s own cash. No Venture Capital or other financial instruments were utilized. The Company continues as a privately held organization focused on steady, organic growth from within.

"Fostering the growth of our technology businesses statewide is essential to a strong Wisconsin economy and I am working hard to grow our statewide technology base," Governor Jim Doyle said. "I am pleased that we could provide a $6 million Department of Commerce Industrial Revenue Bond allocation to help Cambridge Major Laboratories expand and create 23 (new) family-supporting jobs."

“The intent of the new facility is to add larger scale manufacturing to our traditional R&D and small scale cGMP production of clinical and commercial Active Pharmaceutical Ingredients (“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 development to post-NDA in a full GMP environment, eliminating the cost of tech transfers or revalidation of projects 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 decided to build the new facility in Germantown Wisconsin 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 Contract Research and Manufacturing Organizations. At least a dozen Midwest cGMP custom synthesis players are vying for high value projects against competition on the East and West Coasts. The lower 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 has been a real success story the past few year in an otherwise shaky custom chemical marketplace”, said Brian Scanlan, Vice President of Business Development for Cambridge Major. The Company is now well-positioned as we move into the new facility based on a number of factors”, “First, the activity in the CRO/CMO market has significantly picked up in the past 9 months due to an increase in cash into the biotech sector. Second, the Company has made tremendous strides in expanding our customer base during the new construction process. Third, we have strengthened regulatory position, and our past two FDA pre-approval inspections yielded no Form 483 observations. All of these factors combined bode very well for a successful transition into the new facility and a very bright future for Cambridge Major”.

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 qualification and commissioning of the new site is complete. Transfer of validated processes will occur one-by-one until complete. Once in the new facility, Cambridge Major will vacate it current site which is currently for sale.

 

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Cambridge Major Laboratories, Inc. | W130 N10497 Washington Drive | Germantown, WI 53022 | 262-251-5044 | Fax 262-251-5577