Cambridge Major Laboratories Breaks Ground on Manufacturing Site

New facility to be the most modern and sophisticated API site in the US


 


May 15, 2008 Germantown, WI USA: Cambridge Major Laboratories today announced a major expansion into large scale Active Pharmaceutical Ingredient (API) manufacturing. On June 5, 2008 the company will be breaking ground on a new 120,000 square foot, state-of-the-art API manufacturing site next to its headquarters in Germantown Wisconsin USA. The facility is designed with multiple GMP manufacturing suites capable of producing multi-ton quantities of API, and is in response to the company’s large and growing pipeline of late developmental and commercial API’s. Completion is scheduled for August of 2009.


 


The facility will house initially six manufacturing suites with reactors up to 2000 gallon scale with complete isolation and containment. In addition, the facility will house several vessels for hydrogenation and cryogenic reactions, giving the site maximum flexibility and utility. The facility has been designed to accommodate additional manufacturing suites up to 4000 gallon scale, and these will be built out as the needs arise.


 


Cambridge Major opened in a new state-of-the-art API development and small-volume manufacturing site in Germantown in 2004, and this facility is currently approaching the maximum of its operating capacity. As such the company requires more capacity for later stage clinical and commercial API’s. Altogether the company has three API development sites in the US and Europe that will feed large scale manufacturing opportunities into the new site. The company is expected to complete over 400 developmental projects in 2008.


 


“It is vitally important for us to extend our service offerings as we have numerous projects in Phase III clinical trials, and our desire is to retain the technology and customers for the initial several years of commercial manufacturing. Since there will be no tech transfers or re-validations of processes and suppliers, delivery of API should be guaranteed along with significant time and cost savings. This will also free additional capacity in our existing developmental plants, in particular where cryogenic reactions and hydrogenations are part of the process” said Michael Major.


 


As part of Cambridge Major’s growth strategy announced in 2007, it is investing internally and through acquisition to continue to drive the 30 percent annual growth rate the company has experienced since its inception in 1999. Recently, Cambridge Major announced multi-million dollar investments in its development facilities in the US and Europe including new R&D and analytical laboratories, as well as additional pilot plant capacity in its facility in Weert, Netherlands.. These investments will add more than 30 percent to the company’s development capacity.


 


Cambridge Major Laboratories, Inc. is a leading global service-based chemistry outsourcing partner to the pharmaceutical and biotechnology industries, producing pharmaceutical intermediates, Active Pharmaceutical Ingredients, and other fine organic chemicals.  The Company specializes in chemical process development and advanced multi-step organic synthesis, and operates out of three facilities in the US and Europe. The Company has been FDA inspected and approved for cGMP manufacturing.  Visit us at www.c-mlabs.com.