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SAFC Biosciences(R) Defines Hydrolysate Components That Enhance Chinese Hamster Ovary (CHO) Cell Line Protein Production

Friday, September 18, 2009 General News J E 4
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ST. LOUIS, July 29 SAFC Biosciences(R), a business segment within SAFC(R), a member of the Sigma-Aldrich Group (Nasdaq: SIAL), announced today that it has developed a new, chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials. The introduction of EX-CELL(R) CD Hydrolysate Fusion marks the Company's continued focus on raw material characterization (http://www.safcbiosciences.com/ChemicallyDefinedComponents).

Scientists at SAFC Biosciences have determined that an ideal method for biopharmaceutical manufacturers to increase process consistency and reproducibility, while mimicking the productivity and quality profile results from their current hydrolysate-containing processes, is to fully characterize and define those components contained within them. As a result of these studies, EX-CELL CD Hydrolysate Fusion, a synthetically produced animal-component free, chemically defined alternative to undefined hydrolysates, has been created for use in CHO, NS0 and Sp2/0 biopharmaceutical production processes. The liquid version (Product No. 14700C) is formulated as a 20X concentrated supplement designed to have minimal pH and osmolality impact upon addition. For additional flexibility, a readily soluble dry powder version (Product No. 24700C) is also available.

EX-CELL CD Hydrolysate Fusion was developed utilizing Sigma-Aldrich's unique analytical capabilities and expert biological assay development knowledge. This partnership of technology and expertise enabled SAFC Biosciences to develop the first known chemically defined hydrolysate replacement. Matt Caple, SAFC Biosciences Director of Cell Sciences and Development, states: "The capacity for hydrolysates to exert substantial positive impact on cell growth and/or protein production is well documented. But, the undefined and variable nature of these components still inhibits the pursuit of highly controlled and defined pharmaceutical production processes. EX-CELL CD Hydrolysate Fusion resolves this challenge by delivering a fully defined raw material."

Bruce Lehr, SAFC Biosciences Director of Marketing, states: "Raw material understanding and characterization is a leading concern for biopharmaceutical manufacturers interested in mitigating risk. They desire to mitigate supply risk and production variability stemming from the use of undefined or adulterated raw materials in their process. Control of this variable enables manufacturers to design quality into their process instead of testing for it at the end. EX-CELL CD Hydrolysate Fusion is proof that greater raw material definition is possible through advanced analytical techniques."

Further information on the EX-CELL CD Hydrolysate Fusion revolution can be found at (http://www.safcbiosciences.com/ChemicallyDefinedComponents)

About SAFC Biosciences: SAFC Biosciences is a leading provider of cell culture materials and development services for upstream and downstream processes in the biopharmaceutical industry. Providing an integrated services package in mammalian cell culture media development, along with analytical and regulatory support, SAFC Biosciences employs a wealth of industry experience and scientific know-how to deliver reliable, consistent solutions that accelerate customer success - from development through to commercialization. The unit has a 35-year history as a manufacturing partner providing leading biopharmaceutical companies with the broadest range of highly customized products and services possible.

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(R), SAFC Supply Solutions(R), SAFC Biosciences(R) and SAFC Hitech(R) - and had annual sales of $620 million in 2008. SAFC is one of the world's top 10 fine chemical companies. For more information about SAFC, visit www.safcglobal.com.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company. Its chemical and biochemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic 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 38 countries and has 7,800 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.

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 Companies' expectations, goals, beliefs, intentions and the like, which involve assumptions regarding the Companies' operations and conditions in the markets the Companies serve. The Companies do not undertake any obligation to update these forward-looking statements.

SAFC(R), SAFC Biosciences(R), SAFC Supply Solutions(R), SAFC Hitech(R), SAFC Pharma(R), and Sigma-Aldrich(R) are registered trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.

SOURCE Sigma-Aldrich
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