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SAFC Pharma Commits to Major Expansion of High Potency API Production at Madison Site

September 4, 2008
St. Louis, MO - September 4, 2008 SAFC Pharma™, a focus area within SAFC®, a member of the Sigma-Aldrich Group (NASDAQ: SIAL), today officially announced details of a $30 million expansion plan to its Madison (Wisconsin) facility, designed to significantly increase its capacity to produce commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs). The investment includes the purchase of 15 acres of green space in Verona (Wisconsin), near its existing HPAPI production site, where the company will build a new 45,000 sq. ft. manufacturing facility that will house commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters. Construction of the new plant is expected to be complete by year-end 2009.

The new facility’s design will maximize efficiencies and safe handling in high potency development and adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The site will seek Safebridge® certification upon its completion. The facility will include state-of-the-art development laboratories, a 150 liter mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4,000 liters. Specially designed quality control laboratories, a potent compound packaging area and warehouse and office space, plus expansion space, will be featured in the building.

“Currently, there is minimal manufacturing capacity to support market demand for large-scale HPAPI production,” said Dave Feldker, SAFC Pharma Vice President of Sales and Manufacturing, U.S. “We are committed to providing customers with the best possible HPAPI manufacturing services, and our new investment at Madison will enable us to continue to meet the increasing demand for HPAPI production and put us at the forefront in manufacturing commercial-scale high potency materials.“

Following this expansion, SAFC has invested more than $75 million in developing its HPAPI manufacturing capabilities in recent years. The Company has announced a total of $45 million in HPAPI expansions over the last 18 months, including a recently completed $4.5 million extension of its cGMP pilot plant and kilo-lab capacity, and operations have begun at its new biologic-HPAPI conjugation suite in St. Louis, Mo. SAFC Pharma has also invested in a major facility in Jerusalem, Israel, for large-scale production of bacterial and fungal fermentation-derived HPAPIs.



About SAFC: SAFC® 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™, SAFC Supply Solutions®, SAFC Biosciences™, and SAFC Hitech™ – 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 about SAFC, visit 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 8,000 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 www.sigma-aldrich.com.

SAFC®, SAFC Supply Solutions® and Sigma-Aldrich® are registered trademarks and SAFC Pharma™, SAFC Biosciences™ and SAFC Hitech™ are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.
Safebridge® is a registered trademark of Safebridge Consultants, Inc.

 



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