ST. LOUIS, Oct. 2 /PRNewswire-FirstCall/ -- SAFC(R), a member of the Sigma-Aldrich(TM) Group (Nasdaq: SIAL), has announced its plans to begin construction of a new cGMP potent active pharmaceutical ingredients (APIs) conjugation suite at its Pharma sector's St. Louis manufacturing campus. This addition is expected to support oncology drug substance requirements that demand a combination of small molecule chemistry, containment engineering, highly-regulated biologics manufacturing and extensive Quality Control capabilities.
Focused on the oncology drug niche, the new suite will enable the conjugation of highly potent active pharmaceutical ingredients (HPAPIs) to a variety of targeted delivery molecules, including monoclonal antibodies, for the fast-growing anti-cancer market. The new 600 sq. ft conjugation suite, expected to be operational in late 2007, will be SafeBridge(R) certified and can accommodate early-stage clinical supplies of potent conjugated APIs, with capabilities to expand production into commercial-scale, handling multi-Kg quantities of conjugated HPAPIs per batch.
SAFC President, Frank Wicks, commented, "High potency conjugation is an exciting new technology that demands a very special combination of specific skills. Adding HPAPI conjugation capacity enables SAFC to further vertically integrate our contract manufacturing services to pharmaceutical companies that are developing novel cures for cancer. SAFC is a leading producer of many small molecule HPAPIs and has been performing non-potent conjugations for over 30 years. Adding specialized high-containment biologic capacity for performing potent conjugations was a logical extension to our business."
This investment is in addition to SAFC's recently announced plans to add HPAPI assets in the U.S. and Israel, and is the third in a sequence that markedly enhances SAFC's capacity and capabilities in HPAPI manufacturing. These plans include the $4.5 million expansion to introduce additional cGMP pilot plant and kilo lab capacity at the Safebridge-certified SAFC Madison, Wisconsin facility and its $12 million, 38,000 sq. ft. expansion program that was completed in 2006. The second HPAPI-focused development is the $29 million investment planned to expand fermentation capacity at the Sigma-Aldrich Jerusalem, Israel facility, due for completion in 2009.
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.
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 $500 million in 2006. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC visit http://www.safcglobal.com.
Sigma-Aldrich(TM) 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 http://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) and SAFC Supply Solutions(R) are registered trademarks of Sigma-Aldrich Biotechnology L.P.
Sigma-Aldrich(TM), SAFC Pharma(TM), SAFC Biosciences(TM) and SAFC Hitech(TM) are trademarks of Sigma-Aldrich Biotechnology L.P.
Safebridge(R) is a registered trademark of Safebridge Consultants, Inc.
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