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SAFC Biosciences(R) and Vivalis Collaborate to Optimize Cell Culture Media for Vaccines Production

Posted on: Wednesday, 22 April 2009, 23:01 CDT

ST. LOUIS, April 23 /PRNewswire-FirstCall/ -- SAFC Biosciences(R), a business segment within SAFC(R), a member of the Sigma-Aldrich Group (Nasdaq: SIAL), today announced the introduction of EX-CELL(TM) EBx(R) cell growth and viral production media designed exclusively to support Vivalis' (NYSE Euronext: VLS) EB66(R) duck cells used in the commercial production of prophylactic and therapeutic vaccines. The new EX-CELL EBx media is expected to further enable EB66 licensees in the development of viral vaccine therapeutics. In addition, Vivalis plans to use the media in the cGMP manufacture of vaccine lots to support phase I/II clinical trials.

Vivalis, a leader in embryonic stem cell technology, has developed its fully-documented EB66 cell line from duck embryonic stem cells. The cell line fulfils all current industrial specifications for biologics manufacturing while retaining most of the desirable features of embryonic stem cells, such as genetic stability and indefinite cell proliferation. The EB66 cell line also provides key qualities for industrial applications, including growth in serum-free medium, proliferation in bioreactors at high cell densities such as suspension cells, and demonstrates high susceptibility to a broad range of genetically engineered and wild type animal and human viruses.

Commenting on the introduction of EX-CELL(TM) EBx(R), Bruce Lehr, SAFC Bioscience's Marketing Director, said: "Following our strategy of providing customer-centric solutions, we have worked closely with Vivalis to develop these new media to cGMP standards. Looking ahead, we expect to continue expanding our serum-free virus/vaccine media offer to keep pace with the market's burgeoning demand for safer, faster, more economical production processes."

Pierre Miniou, Vivalis Director, Business Development, added: "The EB66(R) cell line has created an immediate impact in the market as it circumvents the quality and quantity control issues associated with traditional chicken egg and primary chicken embryo fibroblasts, while eliminating the risk of contamination and the costs associated with serum for growing the fibroblasts. EB66 cells are fast becoming the recommended industry alternative for the safe, cost effective manufacturing of viral vaccines and recombinant proteins for human and veterinary use. This cell line has already been very well received by industry and has been licensed by pharmaceutical and biotechnology companies worldwide."

EX-CELL EBx media are available through SAFC Biosciences customer services as cGMP grade material. Further information can be found at www.safcbiosciences.com, by calling +1.913.469.5580 or by emailing info-na@sial.com.

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 Vivalis: VIVALIS (NYSE - Euronext: VLS) is a biopharmaceutical company that provides innovative cell-based solutions to the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of viral diseases. VIVALIS' expertise and intellectual property are exploited in three main areas:

1. The development and manufacturing of vaccines. VIVALIS offers research and commercial licenses for its EB66(R) cell line, derived from duck stem cells, to pharmaceutical and biotechnology companies for the production of vaccines. Vivalis receives up front, milestones, and royalties on its licensees' net sales.

2. The development of production systems for recombinant proteins and monoclonal antibodies. VIVALIS licenses its EB66 cell line for the production of recombinant proteins to biotechnology and pharmaceutical companies. Vivalis receives up front, milestones, and royalties on its licensees' net sales.

3. The construction of a portfolio of proprietary products in the area of vaccines and anti-viral molecules (hepatitis C).

Based in Nantes (France), VIVALIS was founded in 1999 by the Grimaud group (1,450 employees), the second largest group worldwide in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES bio-cluster. Learn more about Vivalis at www.vivalis.com

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(R) and SAFC Hitech(TM) - and had annual sales of $624 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 Corp.

Source: PR Newswire

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