SAFC Completes Expansion of High-Potency Fermentation Capabilities at Israel Site

PARIS and ST. LOUIS, Oct. 6 /PRNewswire-FirstCall/ -- CPhI Worldwide -- SAFC, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL), today announced the completion of its state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC’s contract manufacturing capabilities in large molecule recombinant proteins and small molecule Active Pharmaceutical Ingredients (APIs) through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.

The 50,000 sq. ft. cGMP fermentation expansion, which is expected to begin production in October 2010, will focus on niche fermentation of APIs and bulk drugs, producing 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. Capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation, as well as explosion-proof suites.

“Fermentation is a long-standing technology, yet new applications have been recently discovered, including the synthesis of high potency compounds, which is a major growth area currently driving contract manufacturers such as SAFC to look beyond traditional active pharmaceutical ingredient (APIs),” said SAFC President, Gilles Cottier. “The Jerusalem expansion builds upon over 30 years of Sigma-Aldrich experience in the development and manufacture of hundreds of microbial-derived products, and is expected to help SAFC augment its industry-leading strategy of strength and expertise in emerging, highly-specialized technologies and difficult to manufacture products.”

At the Jerusalem facility, SAFC employs E.coli, Streptomyces sp., filamentous fungi and yeast, including risk group 2 human pathogens, across a wide product portfolio that includes small organic molecules and peptides, as well as larger molecules such as proteins, lipids and carbohydrates or macromolecules.

“We believe a primary differentiator at our Jerusalem site is our capability to safely manufacture niche small molecule products and biologics such as natural or recombinant proteins,” added Cottier. “In addition to having industry-leading techniques, capability and infrastructure to manufacture fermentation derived HPAPIs, the site is a multi-disciplinary, full-service facility offering purification and analytical expertise associated with fermentation technology such as microbiology, organic chemistry, biochemistry and molecular biology.”

The foregoing release contains forward-looking statements that can be identified by terminology such as “is expected,” “expected to help,” or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived therefrom. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any of Sigma-Aldrich’s’ products will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding these products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company’s assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich’s current Form 10-K on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About SAFC: SAFC is the custom manufacturing and services business unit of Sigma-Aldrich Corporation. We are recognized as a top 10 global fine molecule supplier and trusted manufacturer of specialty chemicals and biologics for the life science and high technology industries. Utilizing global “Centers of Excellence” and dedicated manufacturing facilities, SAFC can resolve development and manufacturing challenges and accelerate the production of custom materials. Our rich portfolio includes high-purity inorganic materials for high technology applications, cell culture products, services for biopharmaceutical manufacturing and biochemical production, and complex, multi-step organic synthesis of APIs and key intermediates. 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 40 countries and has 7,600 employees providing excellent service worldwide. Sigma-Aldrich is committed to Accelerating Customer Success through Innovation and 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.

SAFC®, SAFC Hitech® and Sigma-Aldrich® are registered of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co. Safebridge® is a registered trademark of Safebridge Consultants, Inc.

SOURCE Sigma-Aldrich

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