Cambridge Major Laboratories Active Pharmaceutical Ingredients Facility, Germantown, WI, USA

Cambridge Major Laboratories Inc is currently constructing a new larger active pharmaceutical ingredients (API) production facility in Germantown, Wisconsin, USA. The new 30,000ft² facility, costing $6.2 million, should be completed and ready for validation by the last quarter of 2004. The new facility is being built to allow the company to compete more effectively for larger scale custom API synthesis projects.

Cambridge Major manufactures APIs for pharmaceutical and biotechnology companies both in the United States and internationally. The company operates at two other sites in Wisconsin; once the new facility is fully operational these will close and the company will operate more efficiently from the new custom facility. The facility is being constructed on a new industrial park on the east side of Germantown.

CONSTRUCTION AND FACILITIES

The new facility will incorporate 20 reactors ranging in capacity from 25-500 gallons. There will be specialty equipment to handle large-scale cryogenics and hydrogenation reactions. There will be two main reactor bays able to handle 500 gallons each. The site will also include two mini pilot plant suites, five Good Manufacturing Practice (GMP) kilo lab suites, four process R&D laboratories, a spectroscopy suite and two high potency suites.

The intention behind the new facility is to increase the scope of the company by the addition of the potential for large-scale manufacturing in addition to R&D and small-scale production of clinical and commercial APIs. The company believes that by consolidating R&D and GMP manufacturing under one roof they can take projects from preclinical development to the regulatory filing stage and further. In this way the cost of technology transfer in scale up procedures can be minimized and revalidation of projects at a new site avoided.

PLANT OUTFITTING

The new facility is being outfitted with equipment acquired from various chemical plants in North America, which have closed down due to the economic downturn. In particular the assets of the former Oread API plant were acquired in 2002. The whole pilot plant was purchased by Cambridge Major for $5 million. The plant will still require two 500-gallon reactors, which will be custom made, as well as solids handling equipment, glove box technology and other process and analytical instrumentation. The two-story plant will also include low temperature storage facilities for temperature and light sensitive reagents and warehousing facilities for APIs.

CAMBRIDGE MAJOR PAST AND FUTURE

The company is currently working on the validation of the synthesis of six generic drugs. The small size of the current facility at 13,000ft² is a factor which puts off potential customers. The company focuses on niche (low volume and orphan) commercial APIs. This means the company has the smaller manufacturing capacity to produce these specialist compounds for a viable cost. The new facility should allow the company to handle larger-scale commercial runs of 50t to 500t of API material for major drug manufacturers. Cambridge Major would like to attract custom from mid-size pharmaceutical companies specializing in generic and branded drugs.

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