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SAFC Expands Hi-Potency API Manufacturing and Introduces Solid-Form Testing at Its Madison Facility
Date:8/29/2007

ST. LOUIS, Aug. 29 /PRNewswire-FirstCall/ -- SAFC(R), a member of the Sigma-Aldrich Group (Nasdaq: SIAL), has announced a $4.5 million capacity expansion program at its flagship SAFC Pharma(TM) high-potency API (HPAPI) facility in Madison, Wisconsin. The program, scheduled for commission in early 2008, will add additional cGMP pilot plant and kilo lab capacity and complement the new XRPD (X-ray Powder Diffraction) analytical equipment for advanced solid form testing due to become operational this month.

These developments build upon existing capabilities and expertise in potent compound handling at the Safebridge(R)-certified SAFC Madison facility and add to a $12 million, 38,000 sq. ft. expansion program completed in 2006.

New HPAPI Assets:

In the $4 million expansion, SAFC is adding additional capacity to its custom HPAPI manufacturing by introducing two 400-liter cGMP pilot plant reactors and two 100-liter cGMP portable jacketed reactors into a 1200 sq.ft. dedicated, large-scale kilo lab. The addition will enable larger-scale chromatography for process purification, catering to future business requirements.

For solid-form testing and analysis, SAFC Pharma has installed and qualified a Bruker D8 Advance X-ray Diffractometer in a new dedicated analytical laboratory, providing U.S. customers with on-site cGMP and XRPD analysis of potent compounds. Rapid sample testing at the Madison site combines with data analysis and evaluation performed at SAFC Pharmorphix(TM) facilities in the U.K. Acquired in mid-2006, SAFC Pharmorphix specializes in solid-form research and is completing a multi-phase, $1.2 million expansion program at its labs.

SAFC President, Frank Wicks, comments, "As regulatory r
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SOURCE Sigma-Aldrich Group
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