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SAFC Pharma Completes Large-Scale API Manufacturing Expansion in Ireland

September 29, 2008

ST. LOUIS, Sept. 29 /PRNewswire-FirstCall/ — SAFC Pharma(TM), a focus area within SAFC(R), a member of the Sigma-Aldrich Group , today announced that a new reactor at its Arklow (Ireland) manufacturing site has begun operation, expanding the facility’s capacity for large-scale active pharmaceutical ingredient (API) manufacturing by approximately 15%. The new reactor is the latest in a series of investments designed to enhance production capacity and expand capabilities at the Arklow site, which is the company’s global center for the production of commercial and late-stage APIs and advanced intermediates.

The $4-million project involved the installation and start-up of a 6,000 liter Hastalloy(R) reactor for large-scale API manufacturing, increasing the total capacity at the site to 96,000 liters, with a reactor range from 250 to 8,000 liters. This latest investment adds capacity for both large- and small-scale manufacturing and improves upon the site’s award-winning environmental performance. The Arklow site is a recognized leader in setting environmental standards and received the PharmaChem Ireland’s Responsible Care 2006 Award in the “Environment” category for development of an imaginative approach to reduce and recycle its solvent waste from API processing.

Commenting on the latest expansion in SAFC’s global manufacturing, SAFC Pharma Vice President Europe, Dr. Michael Harris commented, “Our continued investment in capabilities and capacity is a direct reflection of SAFC’s long-term commitment to meeting customer requirements for API manufacturing. Our continuing investments in facilities and personnel support the growth of SAFC Pharma and underline our position as an industry leader whose focus includes the responsibility to reduce our environmental footprint.”

This latest investment complements two additional expansion projects at the Arklow site: the building of a $2.25-million, 15 kg capacity pilot-scale filter dryer designed to double the facility’s current capacity for small-scale (10 kg-150 kg) manufacturing of APIs, due for commission in third-quarter 2009; and a $1.8-million expansion of the site’s cGMP warehouse capacity, also scheduled for completion in 2009.

“Enhancements to our Ireland site help us strengthen our position as the leading pipeline partner for the pharmaceutical industry, offering complete support for the development, manufacturing and testing of APIs – from preclinical to commercialization stages,” concluded Harris.

The 64,000 cubic meter Arklow complex is cGMP, FDA and IMB inspected and fully validated. It supports customers with expertise in new process evaluation, process development validation and technology transfer. The site’s special process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and it is one of the industry’s few sites to offer large-scale simulated moving bed (SMB) chromatography for chiral separations.

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 Pharma(TM), SAFC Supply Solutions(R), SAFC Biosciences(TM), and SAFC Hitech(TM) – and had annual sales of nearly $600 million in 2007. SAFC is one of the world’s 10 largest fine chemical businesses. For more information, visit http://www.safcglobal.com/.

About Sigma-Aldrich: Sigma-Aldrich: is a leading Life Science and High Technology company. Its 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. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 36 countries and has 7,900 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 its award-winning Web site at http://www.sigma-aldrich.com/.

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), SAFC Supply Solutions(R) and Sigma-Aldrich(R) are registered trademarks and SAFC Pharma(TM), SAFC Biosciences(TM) and SAFC Hitech(TM) are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co. Hastelloy(R) is a registered trademark of Haynes International, Inc.

Photo: http://www.newscom.com/cgi-bin/prnh/20050215/CGSIGMAALLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com

Sigma-Aldrich

CONTACT: Dr. Frank Wicks, President, SAFC, +1-314-286-8008; or Media,Mr. Mark Button of Impress Public Relations, +1-408-310-2168,mark@impress-pr.com, for Sigma-Aldrich

Web Site: http://www.safcglobal.com/http://www.sigma-aldrich.com/




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