


FALL 2009

UPCOMING EVENTS

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

	Informex 2010
	February 16-19
	San Francisco, CA

IN THIS ISSUE

Powerful new Compounds. . .

Controlled Substance Capability

Porphyrin Chemistry Expertise

Cambridge Major Certified Compliant with ChemStewards® Program

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news at CML

CML Dedicates Large Scale API

Manufacturing Facility

US LARGE-SCALE MANUFACTURING FACILITY

CML dedicated its new large scale Active Pharmaceutical Ingredient (API) plant on July 30, 2009. The event was attended by approximately 300 people with Wisconsin Governor James Doyle giving the keynote address. The theme of the event was reinvestment in domestic manufacturing infrastructure, and many of the speakers noted the need for a balance between lower cost off-shore manufacturing with the supply chain security that domestic manufacturers provide.

KEY NOTE SPEAKERS - Brian Scanlan, WI Governor Doyle, Professor Michael Santoro, Dr. Michael Major, Chancellor Carlos Santiago

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	Controlled Substance Capability Did you know CML can produce controlled substances? CML-Europe has an active license from the Dutch government to produce controlled substances. We maintain a general license which requires CML-Europe to pass annual audits to ensure that we comply with local law, have the proper SOP’s, and can proide secure storage necessary to properly store these compounds. Click Here to read more

	Porphyrin Chemistry Expertise Many of the challenges CML are asked to confront relate to the translation of a research scale synthesis into a process appropriate to deliver clinical drug substance. Timelines are usually very aggressive, and CML uses all our experience to minimize risks whilst at the same time meeting all quality and regulatory requirements. One of the most challenging projects we have ever faced was recently completed: the scale-up of a complex porphyrin: CML successfully completed the synthesis of 1 kg of material under cGMP at our facilities in Weert. THE COMPLEXITY OF PORPHYRIN Click Here to read more

Company demonstrates commitment to continuous EHS&S improvement

Cambridge Major Laboratories development and manufacturing facility has completed requirements for certification and compliance with the Society of Chemical Manufacturers and Affiliates (SOCMA) ChemStewards program.

Cambridge Major is being recognized for its successful efforts to go above and beyond the minimum for federal EHS&S compliance, build customer confidence and community trust, and strengthen product stewardship.

“I am very proud of our accomplishments in the areas of Health, Safety, Environmental, and Security compliance.” Said Michael W. Major, Ph.D., D.Sc., CEO of Cambridge Major. “The ChemStewards certification demonstrates our firm commitment to EHS&S. We have invested heavily in personnel, and have invested millions in ensuring that our facilities exceed all environmental standards.”

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