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SAFC to Expand High-Potency API Fermentation Capabilities

$29 Million Expansion of Israel Manufacturing Site

ST. LOUIS, Sept. 26 /PRNewswire-FirstCall/ -- SAFC(R), a member of the Sigma-Aldrich(TM) Group (Nasdaq: SIAL), has announced a $29 million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel. The site enhancement will enable SAFC Pharma(TM) to provide process development and cGMP manufacturing to customers requiring large-scale, high-potency, toxic or hazardous drug substances (large molecule HPAPIs).

The biologics area exploits over 30 years of Sigma-Aldrich's expertise in research, development and scale-up of fermentation-derived products in Israel and close technology links to Israel's academic and R&D communities. Scheduled for completion in the first quarter of 2009, the 50,000 sq. ft. high-potency fermentation expansion will focus production on secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. A 30,000 sq. ft. area of the new facility has been designed to be Biosafety Level 2 compliant -- enabling manipulation of human pathogens. Site capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation.

The new capabilities are expected to expand SAFC Pharma's High Potent Active Pharmaceutical Ingredient (HPAPI) offering to include fermentation-derived HPAPI manufacturing, complementing the multi-step organic synthesis flagship facility at its Madison, Wisconsin location.

Commenting on the investment, Frank Wicks, SAFC President, said, "This expansion builds on the fermentation track record of our Jerusalem facility while adding significantly to our HPAPI capacity. It is consistent with SAFC's strategy to extend the range and scope of coverage in niche technologies and APIs for biologics sectors."

This planned expansion complements other recent St. Louis enhancements of SAFC Pharma's biotechnology facilities, including the 25,000 sq. ft. cGMP purification and manufacturing facility for transgenic plant and other non-animal derived protein drug substances and its segregated partner, the 6,000 sq. ft. purification suite for animal-derived proteins located in St. Louis, Missouri.

SAFC Pharma is focused on cGMP manufacturing, process development and contract services for small organic APIs and advanced intermediates, and the development of large molecule biopharmaceuticals.

About SAFC: SAFC(R) is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas -- SAFC PharmaTM, SAFC Supply Solutions(R), SAFC BiosciencesTM, and SAFC HitechTM -- and had annual sales of nearly $500 million in 2006. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC visit

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. We have customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use our products. Sigma-Aldrich operates in 36 countries and has 7,700 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Leadership in Life Science, High Technology and Service. For more information about Sigma-Aldrich, please visit our award-winning Web site at

Cautionary Statement: This release contains forward-looking statements relating to future performance, goals, strategic actions and initiatives and similar intentions and beliefs and other statements regarding the Company's expectations, goals, beliefs, intentions and the like, which involve assumptions regarding the Company's operations and conditions in the markets the Company serves. The Company does not undertake any obligation to update these forward-looking statements.

SAFC(R) and SAFC Supply Solutions(R) are registered trademarks of Sigma-Aldrich Biotechnology L.P.

SAFC PharmaTM, SAFC BiosciencesTM and SAFC HitechTM are trademarks of Sigma-Aldrich Biotechnology L.P.

SOURCE Sigma-Aldrich
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