UPCOMING EVENTS

	ChemOutsourcing
	September 14-16
	Long Branch, NJ

	CPhI Worldwide 2009
	October 13-15
	Feria de Madrid, Spain

	Informex 2010
	February 16-19
	San Francisco, CA

IN THIS ISSUE

The New CML Europe; A Closer Look at the Expanded Capabilities

CML-US; Expanded Large Scale API Capabilities

Recent Appointments at CML

CONTACT US

info@c-mlabs.com

262-251-5044

CML Completes Major Expansions in the

US and Europe

In spite of all the negative press surrounding the gloomy economy and global recession, Cambridge Major has some excellent news . . . . we are expanding! With major additions in capacity and capability across our US and European sites, we can offer our customers many more options than ever before.

CML-US CAMPUS

Our decidedly “Invest in the West” strategy runs counter to much of the global pharmaceutical outsourcing sector. As many of our competitors are investing in jobs and manufacturing assets in India and China, CML has invested millions in providing our customers with an enhanced Western-based supply option. And let’s face it, with all of the concerns surrounding drug safety and off-shore suppliers (heparin, melamine contamination, counterfeit drugs, etc.), CML has created a domestic solution that involves a secure supply of Active Pharmaceutical Ingredients that meet the most stringent quality standards at a fair price.

Our investment in Europe involves a major expansion of pilot plant capacity, enabling our Weert (The Netherlands) facility to supply API’s up to hundreds of kilograms. This investment comes only a few months after our announced expansion of R&D, analytical, and GMP kilo laboratories late last year. In the US, we’ve completed construction on one of the most modern and sophisticated large-scale GMP manufacturing facilities in the western hemisphere, with multiple production suites and capacity up to 10’s of metric tons per annum. CML’s dynamic and aggressive reputation, coupled with our growing pipeline of late-stage clinical API manufacturing, will provide a base-load of opportunities into the new facility.

GRANT DRIVE FACILITY-JUNE 2009

Please contact us for more information on how we can provide API development or manufacturing services in any one of our four locations in the US and Europe.

The New CML Europe; A Closer Look at the Expanded Capabilities

CML Europe has just completed a major expansion in pilot plant capacity, adding another 40% in available reactor volume. Work started in November 2008, and commissioning took place in March 2009. The new HEPA filtered state-of-the-art 1000L reactor suite was designed by CML chemists and engineers, with maximum flexibility in mind. The multi-purpose set-up is designed to work under pressure up to 6 bars, and with temperatures from - 25 degrees Celsius up to 160 degrees Celsius. This high-quality installation is fully qualified for GMP manufacture, and illustrates the commitment of CML to continue to support clients as their API projects move up in volume, reducing the number of batches - and hence also shortening project timelines.

NEW REACTOR SUITE

This expansion comes immediately after CML Europe announced the completion of new laboratory capacity in November of 2008. The additional laboratories give CML Europe the opportunity to further broaden expertise for customers who are interested in more specialized chemistry projects. The expanded capability essentially doubles CML Europe’s capacity for process R&D, GMP kilo lab manufacturing, and analytical development.

CML Europe works closely with our clients to provide the optimum tailor-made risk-managed approach to API manufacture, proactively seeking to add value to the projects in which we are engaged.

NEW R&D LAB (above)

NEW GMP LAB

CML-US; Expanded Large Scale API Capabilities

Construction is complete on CML’s 125,000 square foot Active Pharmaceutical Ingredient (API) facility adjacent to our global headquarters in Germantown Wisconsin. Only 13 months from groundbreaking, the facility stands as a showcase for large scale GMP manufacturing of API’s and intermediates. More than 70 cubic meters of reactor capacity in six manufacturing suites, means the facility has the capacity to produce hundreds of kilograms to 10’s of metric tons per annum.

The new site supports CML’s announced strategy in 2007 to provide a complete Western-based API solution from early pre-clinical development through multi-ton commercial manufacture. CML’s three development sites in the US and Europe will funnel late-stage opportunities to this facility.

2000 GALLON REACTOR; CHARGING SUITE (above)

ISOLATION SUITE

Click Here to Join us on July 30, 2009 for the Dedication Ceremony in Germantown Wisconsin, USA.

Key Appointments at Cambridge Major Labs

Professor Peter H. Seeberger; CML Scientific Advisor

CML recently announced the appointment of Professor Peter H. Seeberger as Scientific Advisor. He brings a wealth of knowledge in carbohydrate chemistry and the industrialization of the emerging micro-reactor technology arena. Professor Seeberger is Director at the Max-Planck Institute for Colloids and Surfaces in Potsdam and Professor at the Free University of Berlin as well as Affiliate Professor at the Burnham Institute in La Jolla, CA.

The research in Professor Seeberger’s laboratory has resulted in two spin-off companies: Ancora Pharmaceuticals (founded in 2002, Medford, USA) that is currently developing a promising malaria vaccine candidate in late preclinical trials as well as several other therapeutics based on carbohydrates and i2chem that is commercializing microreactors for chemical applications.

He is the Editor of the Journal of Carbohydrate Chemistry and serves on the editorial advisory boards of eleven other journals. He is a founding member of the board of the Tesfa-Ilg “Hope for Africa” Foundation that aims at improving health care in Ethiopia. He is a consultant and serves on the scientific advisory board of several companies.

Marcel Van Der Sluis; Manager of New Business Development, CML-Europe

Marcel is responsible for developing new business opportunities for CML-Europe. In his new position, he will contribute to the growth of CML by combining his network in chemical research and manufacturing with a thorough knowledge of business processes in large multinational companies.

Prior to CML, he held positions with Syncom and Ciba (recently acquired by BASF). He earned his PhD at the Free University in Amsterdam, and completed his post doctoral studies in Virgil Percec’s group at Case Western Reserve University. There he applied his knowledge of catalysis with the development of block co-polymers prepared via atom transfer radical polymerization (ATRP).

Marcel and his wife, Inger have two daughters and he plays jazz trumpet in a BeBop quintet.

Mark Eugenio; Director of Commercial Development

Mark joined CML in June 2009 as Director of Commercial Development where he will be responsible for focusing on the sales and marketing efforts relating to CML’s new large scale manufacturing facility.

Prior to joining CML, he was the Director of Sales and Marketing for Dishman Pharmaceuticals and Chemicals Ltd. where he managed and grew the North American business for the Indian based CRO/CMO.

Mark has also held key marketing/business development roles for Morton International/Rohm and Haas which is now part of Dow and Montgomery Chemicals. He received his BS in Chemistry from Bridgewater State College.

Randy Mitschka; Manager Supply Chain and Logistics

Randy joined CML as Manager of Supply Chain and Logistics in May 2009. He has held positions in Strategic Sourcing and Purchasing with Abbott Labs and Pfizer in Groton, CT over a span of 11 years. Prior to that, he spent 8 years with Eli Lilly and 5 years with Aldrich Chemical, in process R&D assignments.

Most recently he held a position with Cedarburg Pharmaceuticals in New Business Development. He received an MS in Organic Chemistry from UW-Milwaukee under Professor James Cook.