ST. LOUIS, Jan. 29 /PRNewswire-FirstCall/ -- SAFC Pharma(TM), a business segment of SAFC®, a member of the Sigma-Aldrich® group (Nasdaq: SIAL - News), today announced that it has commenced operations at its 7,000 sq. ft. state-of-the-art laboratory complex in Carlsbad, CA. Located adjacent to the Company’s existing flagship viral substance production facility, the new laboratories support SAFC Pharma’s biologics offering for customers in the pharmaceutical and biotechnology markets, and complement its existing portfolio of biologics capabilities through process improvement, technology transfers of processes and assays, and characterization of active ingredients.
The new complex includes a dedicated Polymerase Chain Reaction (PCR) facility, a tissue culture laboratory and stability suite supported by microbiology and regular testing labs, and houses a scientific team focused on Quality Control (QC), Process Development (PD), assay development and validation. The new PCR facility consists of separate suites with uni-directional personnel flow for sample processing, reaction assembly and PCR amplification. In addition to PCR assays, the unit is capable of performing cell-based, molecular and immunological assays, as well as analytical assays such as HPLC. All suites are equipped for independent air handling with air pressure gradients to prevent cross-contamination.
On-site QC functions will include environmental monitoring and microbiology, stability, product and raw materials release, plus analysis of in-process samples using advanced instrumentation. All standard operating procedures and protocols to be carried out in the laboratories are designed to follow cGMP guidelines.
Commenting on the commencement of operations, SAFC President Gilles Cottier stated: “Our investment in this world class facility at our Carlsbad campus underlines SAFC’s continued commitment to building capabilities in important emerging new technologies such as viral vaccines and gene therapies - areas where SAFC sees great potential. As new and increasingly complex products make their way to commercialization, SAFC will continue to be strongly positioned to collaborate fully with its partners and customers on the development and production of treatments for cancer, cardiovascular and central nervous system diseases.”
Commissioning of the new laboratories at Carlsbad follows SAFC’s 2008 announcement of a $12 million expansion at the site to construct two fully segregated manufacturing suites. Due to be operational before 2009 year end, these suites will add an additional 8,000 sq. ft. of manufacturing space and enable 100 liter batch production in stirred tank bioreactors and 500 - 1,000 liter batch manufacturing in disposable bioreactors. The expansion will add commercial manufacturing capacity within the current 44,000 sq. ft. site and is planned to be Biosafety Level 2 compliant, allowing manipulation of human pathogens.
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(TM), SAFC Supply Solutions®, SAFC Biosciences(TM), and SAFC Hitech(TM) - 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, visit www.safcglobal.com.
About SAFC Pharma: SAFC Pharma is a complete pipeline partner for the development and cGMP custom manufacturing of complex small-molecule APIs and biologic drug products. It combines world-class project management and chemistry support for all stages of the drug discovery and development process from research and discovery, through pre-clinical and clinical development to commercialization, with a focus on reducing the drug development time-line. SAFC has the widest range of raw materials, highly qualified and experienced staff, state-of-the-art facilities and an integrated portfolio of services, including full analytical and regulatory support and is a leader in emerging technologies, including high-potency APIs, solid-state chemistry, viral products and chemical-biologic API conjugates. For more information visit www.safcpharma.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 37 countries and has 8,000 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 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®, SAFC Supply Solutions® and Sigma-Aldrich® are registered trademarks and SAFC Pharma(TM), SAFC Biosciences(TM) and SAFC Hitech(TM) are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co.
